BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2912240 · Received January 11, 2013

    Report

    Report Number
    3004493922-2013-00094
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CUSTOMER'S DAUGHTER CALLED AND STATED THE BACK CASTER WHEELS ARE BROKE. ALSO, THE PINS WITHIN THE PUMP KEEPS COMING OUT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17199 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other