BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2821835 · Received November 6, 2012

    Report

    Report Number
    1525712-2012-02102
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL DEMOS3GC, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY ONE MONTH OLD. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY REPORTED. THE OWNER'S MANUAL PART NUMBER 1154295 REV.C (DEC-10) WAS ISSUED WITH THIS DEVICE. THE MALFUNCTION HAS NOT BEEN CONFIRMED YET.

    Description of Event or Problem · 1

    THIS IS A DEMO CHAIR. TBM WAS PERFORMING AN IN SERVICE AND THE STROLLER HANDLE BROKE AT THE PIVOT KNUCKLE WHERE THE HANDLE INSERTS INTO THE PIVOT KNUCKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET DEMOS3GC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other