BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2891986 · Received January 1, 2013

    Report

    Report Number
    1525712-2012-03409
    Event Type
    Malfunction
    Date Received
    January 1, 2013
    Report Date
    December 31, 2012
    Manufacturer
    UNKNOWN
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER ALLEGES THE WHEEL FELL OFF. SERIAL NUMBER PROVIDED IS NOT ABLE TO BE VERIFIED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29 NON AC-POWERED PATIENT LIFT 880.5510 FSA UNKNOWN 9805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other