BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBULIFT CLASSIC (POWERED)

    MDR report key: 1624151 · Received March 2, 2010

    Report

    Report Number
    9617021-2010-00033
    Event Type
    Injury
    Date Received
    March 2, 2010
    Date of Event
    February 8, 2010
    Report Date
    March 2, 2010
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DATE OF EVENT IS NOT KNOWN. THE FACILITY REPORTED THAT CAREGIVER HAD JUST FINISHED BATHING, DRYING, AND DRESSING THE PT USING AN AMBULIFT CLASSIC WITH SUB CHASSIS. CHASSIS HAD BEEN ATTACHED TO CHAIR AND LOWERED TO FLOOR, BUT CHAIR DID NOT DISENGAGE AS SAFETY CATCH HAD NOT BEEN RELEASED. CHAIR WAS THEN RAISED SLIGHTLY, SAFETY CATCH RELEASED, AND CHAIR DETACHED FROM JIB. AT THIS STAGE, THE PT FELL FORWARD OUT OF THE CHAIR LANDING ON THE FLOOR AND BANGING HER HEAD. THE SAFETY STRAP WAS NOT FITTED AND ONE ARM ON THE COMMODE CHAIR HAD BEEN RAISED TO ALLOW TRANSFER OF PT. IT WAS REPORTED THAT THE COMMODE SEAT WAS THEN FOUND DETACHED FROM THE COMMODE CHAIR FRAME. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBULIFT CLASSIC (POWERED) PATIENT LIFT - RAISING AID FNG ARJO MED AB LTD. KDA1910

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention