BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3905551 · Received July 1, 2014

    Report

    Report Number
    1525712-2014-03318
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 28, 2014
    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

    THE PROVIDER ALLEGES THAT THE SERVICE INDICATOR LIGHT IS FLASHING 4 TIMES WHICH INDICATED NO OUTPUT COMING FROM THE LEFT MOTOR ON A R51LXP POWER CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383768 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET R51LXP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other