BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2981839 · Received February 27, 2013

    Report

    Report Number
    1525712-2013-01484
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 31, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE TDXSP-MCG CUSTOM POWER WHEELCHAIR WOULD INTERMITTENTLY CHANGED THE SPEED WITHOUT COMMAND, AND THE PATIENT WOULD LOOSE CONTROL OF THE UNIT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84183 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other