BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 5063741 · Received September 9, 2015

    Report

    Report Number
    1525712-2015-04475
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Report Date
    November 10, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL/UPDATED INFORMATION WAS ADDED TO REFLECT THE DEVICE BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MOTORS, CONTROLLER, AND JOYSTICK WERE RETURNED FOR EVALUATION, HOWEVER SUBSEQUENT TESTING COULD NOT VERIFY THE COMPLAINT. THE CONTROLLER AND JOYSTICK PASSED FUNCTIONAL TESTING, AND BOTH MOTORS OPERATED PROPERLY DURING THE BENCH TEST, RUNNING IN THE PROPER DIRECTIONS.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    DEALER STATES WHEN THE JOYSTICK IS IN FORWARD IT GOES REVERSE, IN REVERSE IT GOES FORWARD, RIGHT GOES RIGHT, LEFT GOES REVERSE.

    Description of Event or Problem · 1

    DEALER STATES WHEN THE JOYSTICK IS IN FORWARD IT GOES REVERSE, IN REVERSE IT GOES FORWARD, RIGHT GOES RIGHT, LEFT GOES REVERSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594758 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET 3GAR-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other