BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4131338 · Received October 1, 2014

    Report

    Report Number
    3008262382-2014-01375
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 11, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER, WHEN THE CONSUMER HITS EVEN THE SLIGHTEST THRESHOLD THE CHAIR WILL DISENGAGE THE MOTORS. MOTORS HAVE ALREADY BEEN REPLACED TWICE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610583 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other