Welch Allyn Protocol, Inc.
Beaverton, OR, US
Welch Allyn Protocol, Inc. appears in FDA device records in Beaverton, OR. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 16 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Welch Allyn Protocol, Inc. between 2001 and 2007. The busiest year on record is 2002, with 2. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K070204 | LINK TO ACUITY CLINICIAN NOTIFIER | MSX | Substantially Equivalent | |
| K063419 | MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) | MWI | Substantially Equivalent | |
| K033378 | VITAL SIGNS MONITOR, PROPAQ LT | MWI | Substantially Equivalent | |
| K031740 | VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES | DQA | Substantially Equivalent | |
| K022453 | MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM | DSI | Substantially Equivalent | |
| K021681 | MICROPAQ, MODELS 402, 404 | DRT | Substantially Equivalent | |
| K012451 | PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 | DRT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0633-2014 | The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network. | Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations. | Class II | Terminated | |
| Z-2918-2011 | Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. Welch Allyn Protocol, Inc. Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors. | Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference. | Terminated | ||
| Z-0937-2011 | Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use in and out of the hospital. | Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The loss of the ability to view the patient's Electrocardiogram (ECG) on the screen could cause the user to delay or fail to administer defibrillating shocks needed to resuscitate a patient. | Terminated | ||
| Z-1873-2009 | Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units configured with the appropriate options can also simultaneously monitor temperature and noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and continuously monitor pulse rate. The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals. | The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms. | Terminated | ||
| Z-0349-2011 | ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch Allyn Acuity Central Monitoring System. The affected serial numbers are those less than QC2082880001. The ViewSonic 19" flat panel LCD display Model VG930M is used as part of the Welch Allyn Acuity Central Monitoring System (Acuity System.) The Acuity System consists of a central monitoring station, Acuity System software, and a collection of other commercially available networked products | The 19" Model VG930M ViewSonic flat panel LCD display may have faulty capacitors at certain locations in the power supply section. The faulty capacitors may cause a loss of power to the display resulting in the display screen going dark and loss of both visual and secondary patient alarms. | Terminated | ||
| Z-1656-2009 | Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10") | Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to | Terminated | ||
| Z-1389-2009 | Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") | Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts. | Terminated | ||
| Z-1007-2009 | Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") | Potential for device to deliver less than the programmed energy. | Terminated | ||
| Z-1006-2009 | Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10") | Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm; | Terminated | ||
| Z-1005-2009 | Welch Allyn AED 10 Automated External Defibrillator | Potential for device to shut down prematurely under certain circumstances. | Terminated | ||
| Z-0129-2008 | Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E; | Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient | Terminated | ||
| Z-1223-2007 | Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E) | Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy. | Terminated | ||
| Z-0216-2007 | Propaq LT vital signs monitor, Model 802LTRN | Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT. | Terminated | ||
| Z-0215-2007 | Propaq LT vital signs monitor, Model 802LTON | Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT. | Terminated | ||
| Z-1333-04 | Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00 | Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts. | Terminated | ||
| Z-0538-04 | Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00 | Potential failure to audibly alarm due to speaker hardware component failure. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Welch Allyn Protocol, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain