BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2950880 · Received February 8, 2013

    Report

    Report Number
    3004493922-2013-00278
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER STATED THAT THE PIN THAT OPERATES THE PUMPS HAS BROKEN OFF WHERE IT CANNOT BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55138 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU 9805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other