BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 4853655 · Received June 18, 2015

    Report

    Report Number
    1525712-2015-03465
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE RETURNS DEPARTMENT WHICH FOUND THAT THE MOTOR OPERATES PROPERLY DURING BENCH TEST, WIGGLED WIRES AND BRAKE CAM WITH NO FAILURE, GEARBOX OPERATES PROPERLY DURING BENCH TEST.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEALER STATES HE IS GETTING A LEFT BRAKE FAULT .

    Description of Event or Problem · 1

    DEALER STATES HE IS GETTING A LEFT BRAKE FAULT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398441 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other