BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3112745 · Received May 14, 2013

    Report

    Report Number
    3004493922-2013-01055
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 17, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A BROKEN CAMLOCK BOLT ON THE MAST OF THE GHS350 PATIENT LIFT. THIS EVENT COULD CAUSE PRODUCT INSTABILITY WHICH IN TURN COULD CAUSE USER TO SUDDENLY AND UNINTENTIONALLY BE DROPPED TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212513 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU GHS350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other