BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3884493 · Received June 19, 2014

    Report

    Report Number
    1525712-2014-03063
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THAT INTERMITTENTLY ABOUT 2-3 TIMES A DAY THE CHAIR WILL STOP AND THE SERVICE INDICATOR LIGHT WILL BLINK 4 TIMES WHICH IS AN E04 CODE. PROVIDER STATES WHEN THIS HAPPENS, THE CONSUMER WILL POWER THE CHAIR OFF FOR A WHILE THEN TURN IT BACK ON AND NORMALLY IT WOULD WORK AGAIN UNTIL THE NEXT EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361305 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other