BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBULIFT BSQ

    MDR report key: 358579 · Received October 30, 2001

    Report

    Report Number
    9617021-2001-00171
    Event Type
    Malfunction
    Date Received
    October 30, 2001
    Date of Event
    September 5, 2001
    Report Date
    October 3, 2001
    Manufacturer
    ARJO LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE CARER WAS TRANSFERRING THE RESIDENT OUT OF THE BATH AFTER MAKING SURE THE SAFETY CATCH WAS PROPERLY POSITIONED. JUST BEFORE THE RESIDENT TOUCHED THE FLOOR WITH THE FEET THE CHAIR DETACHED, CAUSING BOTH THE RESIDENT AND THE CHAIR TO FALL TO THE FLOOR. THE RESIDENT COMPLAINED OF BACK PAIN.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE CARER WAS TRANSFERRING THE RESIDENT OUT OF THE BATH AFTER MAKING SURE THE SAFETY CATCH WAS PROPERLY POSITIONED. JUST BEFORE THE RESIDENT TOUCHED THE FLOOR WITH HER FEET THE CHAIR DETACHED, CAUSING BOTH THE RESIDENT AND THE CHAIR TO FALL TO THE FLOOR. THE RESIDENT COMPLAINED OF BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48500 AMBULIFT BSQ PATIENT LIFT FSA ARJO LTD. ABXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN