Pulmonetic Systems, Inc.
Colton, CA, US
Pulmonetic Systems, Inc. appears in FDA device records in Colton, CA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 21 recalls for this company.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Pulmonetic Systems, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Cardinal Health 203, Increcall
- CareFusion 203, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 12 510(k) clearances for Pulmonetic Systems, Inc. between 1998 and 2009. The busiest year on record is 2004, with 2. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR | CBK | Substantially Equivalent | |
| K070594 | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 | CBK | Substantially Equivalent | |
| K060647 | LTV 1200 VENTILATOR | CBK | Substantially Equivalent | |
| K060549 | AUTOMOBILE LIGHTER POWER CORD | CBK | Substantially Equivalent | |
| K051767 | LTV 1000 VENTILATOR | CBK | Substantially Equivalent | |
| K040790 | MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS | CBK | Substantially Equivalent | |
| K040540 | MODIFICATION TO LTV 1000 VENTILATOR | CBK | Substantially Equivalent | |
| K032226 | LTV-1000 VENTILATOR | CBK | Substantially Equivalent | |
| K010608 | MODIFICATION TO LAP TOP VENTILATOR (LTV) | CBK | Substantially Equivalent | |
| K002881 | VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K984056 | LTV 1000 | CBK | Substantially Equivalent | |
| K981371 | LTV 1000 VENTILATOR | CBK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2593-2014 | CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations. | CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre | Class I | Terminated | |
| Z-2006-2012 | CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use. | CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised. | Class I | Terminated | |
| Z-0074-2012 | CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range of life support and critical care applications. The ventilator normally operates from external DC power. When the ventilator is portable, a Removable Battery Pack powers the unit. Devices are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). | CareFusion has identified potential risks associated with the EnVe ventilator manufactured between December 2010 and May 2011. There are 3 issues that can result in ventilation delivery to the patient being interrupted. CareFusion will be contacting facilities to coordinate implementation of the necessary corrective actions. | Terminated | ||
| Z-2205-2010 | Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalation valve, as single patient use (SPU) only patient circuits for adult and pediatric patients. The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: -Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). -Assist/Control, SIMV, CPAP or NPPV modes of ventilation. -Breath types including Volume, Pressure Control and Pressure Support. | CareFusion is recalling the P/N 19189-001 Patient Circuit (SPU W/O PEEP 15ft) because some of the circuit sense lines may have been reversed during the manufacturing process. If the sense lines have been reversed, immediately upon connection of the patient circuit to the ventilator and turning the ventilator on, the ventilator will begin to autocycle (with increased pressure delivered) with both | Terminated | ||
| Z-0857-2010 | Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. | CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion has identified certain device malfunctions that may affect device performance and patient safety in the intended use environment. | Terminated | ||
| Z-1470-2008 | Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. | Terminated | ||
| Z-1469-2008 | Replacement Kit, Power PCBA with Memory PCBA. REF 14425. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. | Terminated | ||
| Z-1468-2008 | Replacement Kit, Power PCBA without Memory Board. REF 14157. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. | Terminated | ||
| Z-1467-2008 | Replacement Kit, Power PCBA with DC power cord. REF 11590. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. | Terminated | ||
| Z-1466-2008 | Viasys healthcare, Pulmonetic Systems LTV 800 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight design. It can operate from an internal battery, external battery or AC power. Applications include long term acute care or short term / recovery room. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447. | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. | Terminated | ||
| Z-1465-2008 | Viasys healthcare, Pulmonetic Systems LTV 900 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight design. It can operate from an internal battery, external battery or AC power. Applications include long term acute care or short term / recovery room. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447. | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. | Terminated | ||
| Z-1464-2008 | Viasys healthcare, Pulmonetic Systems LTV 950 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight design. It can operate from an internal battery, external battery or AC power. Applications include long term acute care or short term / recovery room. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447. | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. | Terminated | ||
| Z-1463-2008 | Viasys Healthcare, Pulmonetic Systems LTV 1000 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight design. It can operate from an internal battery, external battery or AC power. Applications include long term acute care or short term / recovery room. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447. | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. | Terminated | ||
| Z-0186-06 | Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-900 is a prescription medical device suitable for use in institutional, home and transport settings. | Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm. | Terminated | ||
| Z-0185-06 | Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-950 is a prescription medical device suitable for use in institutional, home and transport settings. | Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm. | Terminated | ||
| Z-0184-06 | Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-1000 is a prescription medical device suitable for use in institutional, home and transport settings. | Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm. | Terminated | ||
| Z-0296-05 | Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 1000 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04) | Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator. | Terminated | ||
| Z-0295-05 | Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 900 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04) | Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator. | Terminated | ||
| Z-0294-05 | Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 950 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04) | Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator. | Terminated | ||
| Z-0274-05 | Universal Cable Adaptor (Part #17765-001 and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV series Ventilator, Model 800 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall (FDA Z-1485-04). | Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator. | Terminated | ||
| Z-1485-04 | The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings. | Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation to the patient. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain