Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2693-2014Class II

Minstrel (with scale)

ArjoHuntleigh Polska Sp. zo.o. / initiated 2014-07-28 / Terminated / root cause: design

ARJOHUNTLEIGH POLSKA Sp. z.o.o. began a recall of Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals... on . FDA classified it as Class II and gives the reason as "ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. There is a remote risk concerning the bolt unscrewing from the scale. When the scale and bolt parts are not correctly...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2693-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ArjoHuntleigh Polska Sp. zo.o.
Product
Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lifted from, typically, a bed or chair.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. There is a remote risk concerning the bolt unscrewing from the scale. When the scale and bolt parts are not correctly serviced, or when they receive a sharp blow during or outside of use, it is possible the bolt holding the spreader bar to the scale could unscrew during subsequent use. As a result, the sp
Root cause tag
design
FDA root cause
Device Design
Action
ARJOHUNTLEIGH sent an URGENT - FIELD SAFETY NOTICE letter dated July 28, 2014 to all customers. The letter identified the affected product, problem and actions to be taken. The letters provided customers with two options with how to address this recall: 1) because the devices are close to their 10-year lifetime, customers can return the devices for a trade-in discount that will be applied to the purchase of a new ArjoHuntleigh patient transfer lift; or 2) an ArjoHuntleigh Service Technician will install a new scale with added locking features to the existing unit free of charge. Customers were further instructed to: 1) ensure that all caregivers and users of the devices are given a copy of the letter; 2) place a copy of this letter with the device's instruction for use; and, 3) to complete and return the enclosed Customer Service Response form. For questions or assistance completing the Customer Response Form, please contact ArjoHuntleigh at 1-800-323-1245, ext. 57985 during office hours; Monday to Friday, 8:00am to 5:00pm (CST) or via email at [email protected].
Quantity in commerce
18 Lifts
Distribution
Worldwide Distribution - US Nationwide in the state of MA and the countries of Australia, Germany, and Italy.
Product codes and lots
Model Numbers: HMA0002 and HMB002-US;  Serial Numbers: MPLAT0409W1177 ; MPLAT0410W1213 ; MPLAT0410W1228 ; MPLAT0410W1229 ; MPLAT0410W1231 ; MPLAT0410W1232 ; MPLAT0412W1290 ; MPLAT0412W1296 ; MPLAT0412W1297 ; MPLAT0502W1403 ; MPLAT0502W1404 ; MPLAT0503W1485 ; MPLAT0503W1486 ; MPLAT0504W1518 ; MPLAT0504W1519 ; MPLAT0504W1520 ; MPLAT0504W1531

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2693-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2693-2014Class IITerminatedVoluntary: Firm initiated