BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3081566 · Received April 29, 2013

    Report

    Report Number
    3004493922-2013-00935
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 3, 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

    Additional Manufacturer Narrative · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED.PROVIDER STATES LIFT PARTS, ARM AND THE PLASTIC PIECE, HAS EXPANDED AND THE HOLES ARE ELONGATED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED.PROVIDER STATES LIFT PARTS, ARM AND THE PLASTIC PIECE, HAS EXPANDED AND THE HOLES ARE ELONGATED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185953 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU RPS350-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other