BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2874820 · Received December 16, 2012

    Report

    Report Number
    1525712-2012-03056
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Date of Event
    October 16, 2012
    Report Date
    December 15, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    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 RMA HAS BEEN INITIATED FOR THIS ISSUE. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER ALLEGES THE CONSUMER'S SIP AND PUFF CAME OUT OF HIS MOUTH AND HE HAD TO WAIT UNTIL HE RAN INTO SOMETHING TO STOP. HE RAN INTO THE WALL AND BENT HIS PIVOT TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 IOR INVACARE TAYLOR STREET TDX4-PS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other