BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2930599 · Received January 28, 2013

    Report

    Report Number
    3004493922-2013-00180
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 25, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ALLEGES THAT THE SHIFTER HANDLE AND THE MOUNTING HARDWARE ON A RPS350-1 STAND UP LIFT ARE LOOSE. THIS RELATES TO THE OPENING AND CLOSING OF THE LEGS, STABILITY ISSUE WITH THE LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37624 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU RPS350-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other