BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3051694 · Received April 10, 2013

    Report

    Report Number
    3004493922-2013-00789
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 15, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE FLANGED BEARING IN THE CAM LOCK OF A GHS350 PATIENT LIFT BROKE INTO THREE PIECES. THIS EVENT COULD RESULT IN INCONSISTENT OPERATION OF THE UNIT WITH POTENTIAL INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153765 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU GHS350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other