BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3961884 · Received July 28, 2014

    Report

    Report Number
    1525712-2014-04059
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 8, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT HE BELIEVES THE ENGAGEMENT KNOB DID NOT HAVE STUDS ON THE POWER CHAIR SINCE SHIPMENT. DEALER STATED THERE ARE NO STUDS IN HE POWER CHAIR AT THIS TIME. HE DOES NOT BELIEVE THEY WERE SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437907 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other