BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4242721 · Received November 11, 2014

    Report

    Report Number
    1525712-2014-07807
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 22, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER STATES THAT THE (B)(4) POWER CHAIR HAS LESS THEN 5 MILES ON IT, AND WHEN SHE DROVE IT 6 BLOCKS TO (B)(6) IT JUST DIED. STATES THEN WHEN YOU POWER IT ON IT GIVES THE RIGHT BRAKE ERROR. IF YOU RESET IT AND PUT IT ON RABBIT MODE IT STATES LEFT MOTOR FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725895 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET FDX-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other