BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3083602 · Received April 29, 2013

    Report

    Report Number
    1525712-2013-03353
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 3, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A TDXSIV-HD CUSTOM POWER WHEELCHAIR WHERE THE MOTOR IS LEAKING GREASE AND THE END-USER'S O2 TUBE GOT WRAPPED AROUND THE AXLE. THIS EVENT COULD RESULT IN THE INCONSISTENT OPERATION OF THE UNIT AND POTENTIALLY RESULT IN INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185029 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSIV-HD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other