BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3921168 · Received July 9, 2014

    Report

    Report Number
    3008262382-2014-00234
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 5, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT TRIANGLE VALVE/LEVER STAYS OPEN AND WILL NOT LOCK TO HOLD PATIENT IN PLACE; KEEPS LOWERING AND THE CAREGIVER HAS TO KEEP PUMPING SO THE PATIENT DOES NOT LOWER WHILE TRYING TO STAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400034 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE REHABILITATION EQUIP GHS350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other