BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2954951 · Received February 11, 2013

    Report

    Report Number
    3004493922-2013-00311
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    DEALER ALLEGES THE CABLE THAT HOLDS THE FOOT PLATE IS FRAYING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58849 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU GHS350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other