BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC-POWERED PATIENT LIFT

    MDR report key: 1781289 · Received July 28, 2010

    Report

    Report Number
    1525712-2010-00108
    Event Type
    Injury
    Date Received
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    INVACARE
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A TRANSFER, THE CAREGIVER ALLEGES THE SLING STRAP CAME OFF OF THE LIFT AND THE PATIENT FELL FROM THE SLING AND SUSTAINED A FRACTURED FEMUR. NATURE OF COMPLAINT SUGGESTS A TRANSFER ERROR. CURRENT USER GUIDE COVERS PROPER TRANSFER METHODS. DEVICE HAS BEEN IN SERVICE FOR OVER 7 YEARS. DEVICE MAINTENANCE AND SERVICE HISTORY ARE UNKNOWN. INSPECTION BY THE FACILITY REVEALED NO TORN, CUT, FRAYED OR BROKEN AREA OF THE SLING.

    Description of Event or Problem · 1

    THE FACILITY WAS TRANSFERRING A RESIDENT WHEN THE SLING STRAP THAT SUPPORTED THE RESIDENT'S LEFT LEG ALLEGEDLY CAME LOOSE OR UNDONE FROM THE HOOK, CAUSING THE CONSUMER TO SLIDE OUT OF THE SLING AND FALL ON THEIR LEFT SIDE. THE RESIDENT ALLEGEDLY SUSTAINED A FRACTURED FEMUR AND L1 / T12 SPINAL COMPRESSION FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED PATIENT LIFT 880.5500 FNG INVACARE RPA600-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R