BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2871114 · Received December 12, 2012

    Report

    Report Number
    1525712-2012-02910
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES JOYSTICK WILL NOT TURN ON. JOYSTICK WAS TURNING ON INTERMITTENTLY BEFORE IT QUIT. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 Other