BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2864075 · Received December 10, 2012

    Report

    Report Number
    3004493922-2012-00667
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    December 7, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    WILL LIFT BUT COMES BACK DOWN. IT WAS LEARNED IN SPEAKING WITH THE REPORTER THAT WHEN THE PATIENT WAS UP THE LIFT SLOWLY BEGAN TO COME BACK DOWN. THE LIFT IS NOW IN THE REPAIR CENTER. PARTS HAVE BEEN ORDERED FOR REPAIR AND THE LIFT IS NO LONGER IN USE. BEEN IN USE SINCE 2007. SHE IS UNSURE WHEN THE LIFT BEGAN MALFUNCTIONING. DEMOGRAPHICS ARE APPROXIMATE. THE LIFT WAS MANUFACTURED IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU 9099

    Patients

    Seq Age Sex Outcome Treatment
    1 Other