BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3123170 · Received May 21, 2013

    Report

    Report Number
    9616091-2013-00855
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 2, 2013
    Manufacturer
    INVACARE
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACAE AWARENESS DATE IS (B)(4) 2013. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL (B)(4) 2013.

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE PIVOT LINK WAS BROKEN ON THE TREX28R MANUAL WHEELCHAIR. THIS ISSUE COULD CAUSE PRODUCT INSTABILITY AND THE CHAIR MAY NOT MAINTAIN ITS WEIGHT BEARING STATUS CAUSING THE USER TO FALL OUT OF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223776 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TREX28R

    Patients

    Seq Age Sex Outcome Treatment
    1 69 Other