BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC-POWERED PATIENT LIFT

    MDR report key: 1781264 · Received July 28, 2010

    Report

    Report Number
    1525712-2010-00112
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 28, 2010
    Manufacturer
    INVACARE
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFT HAS BEEN IN SERVICE FOR 9 YEARS AND IS NO LONGER IN WARRANTY. THE USER ALLEGES, DURING A TRANSFER, THE LIFT TIPPED AND THE USER REQUIRED 3 STAPLES FROM THE BOOM IMPACTING THEM DURING THIS INCIDENT. NATURE OF COMPLAINT SUGGESTS A POTENTIAL TRANSFER ERROR. DEVICE SERVICE AND MAINTENANCE HISTORY IS UNKNOWN. CURRENT USER GUIDE COVERS PROPER TRANSFER METHODS. MDR FILED BASED ON ALLEGED SERIOUS INJURY.

    Description of Event or Problem · 1

    THE CONSUMER WAS BEING LIFTED OUT OF BED TO A WHEELCHAIR WHEN THE LIFT ALLEGEDLY TIPPED TO THE SIDE, CAUSING THE MAST TO HIT THE CONSUMER IN THE HEAD. SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED PATIENT LIFT 880.5500 FNG INVACARE RPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention