BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2874242 · Received December 14, 2012

    Report

    Report Number
    3004493922-2012-00697
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. STATES THE LIFT WIL SLOWLY LOWER ITSELF WHEN IT IS SUPPOSED TO BE HOLDING THE PATIENT UP. WILL NOT HOLD WEIGHT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU RHL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other