BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3247750 · Received July 25, 2013

    Report

    Report Number
    3004493922-2013-01619
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 3004493922-2013-01619, INDICTING THE BRAND NAME AS AC POWERED LIFT WITH A COMMON DEVICE NAME OF 880.5500. THE CORRECT BRAND NAME IS NON-AC POWERED PATIENT LIFT WITH A COMMON DEVICE NAME OF 880.5510.

    Description of Event or Problem · 1

    MAST BROKE WITH PATIENT IN LIFT PER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348483 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU RPL450-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other