BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALENTI WITH SCALE

    MDR report key: 286526 · Received July 19, 2000

    Report

    Report Number
    9617021-2000-00088
    Event Type
    Other
    Date Received
    July 19, 2000
    Date of Event
    March 17, 2000
    Report Date
    July 7, 2000
    Manufacturer
    ARJO LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS WHILE TRANSFERRING THE PT AWAY FROM THE BATH AND LOWERING THE SEAT HEIGHT TO ALLOW THE PT'S FEET TO REST ON THE CHASSIS, THE PT LEANED FORWARD AND THE HOIST TIPPED (THE BRAKES WERE ON). NO INJURIES WERE REPORTED. THE SEAT WAS APPROXIMATELY 100MM ABOVE THE BATH EDGE WHEN IT TIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI WITH SCALE PATIENT LIFT FSA ARJO LTD. CDBXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other