BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3250879 · Received July 29, 2013

    Report

    Report Number
    3007231105-2013-00043
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 10, 2013
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT # 3007231105-2013-00043. THIS PRODUCT IS NOT DISTRIBUTED IN THE USA, REPORT SUBMITTED TO THE US FDA WAS NOT NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE (B)(4) BATH LIFT IS ONLY OPERATING INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353499 NON AC-POWERED PATIENT LIFT 880.5510 FSA AQUATEC OPERATIONS GMBH 1471565

    Patients

    Seq Age Sex Outcome Treatment
    1 Other