BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER LIFT

    MDR report key: 823337 · Received January 31, 2007

    Report

    Report Number
    2182305-2006-00042
    Event Type
    Malfunction
    Date Received
    January 31, 2007
    Date of Event
    November 9, 2006
    Report Date
    December 8, 2006
    Manufacturer
    IMS, INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER, BY FACILITY, WHILE ACTIVELY TRANSPORTING A PATIENT, FROM HER BED TO THE RECLINER AND WHILE PATIENT WAS IN A SUSPENDED POSITION THE SHAFT THAT CONNECTS THE CRADLE/SCALE TO THE BOOM CRACKED IN HALF. [THE BREAK OCCURRING JUST ABOVE THE SURFACE OF THE SCALE]. PATIENT WAS ASSISTED TO THE FLOOR AS THE STAFF WAS BEHIND HER AND GUIDED HER AS SHE LANDED ON THE FLOOR ON THE FLOOR. SHE SUSTANINED ONLY A BRUISE TO HER RIGHT A REFERENCE NUMBER HAS BEEN ISSUED TO RETURN THE CRADLE AND SCALE TO MANUFACTURER FOR EVALUATION. IN ADDITION THE MANUFACTURER OF SCALE HAS BEEN NOTIFIED. THIS IS BEING REPORTED UNDER MALFUNCTION, WHICH COULD HAVE RESULTED IN SERIOUS INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PATIENT LIFTER FNG IMS, INC. PRESENCE W/ SCALE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other