BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 5313404 · Received December 21, 2015

    Report

    Report Number
    1525712-2015-05859
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Report Date
    December 11, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL/UPDATED INFORMATION WAS ADDED TO REFLECT THE DEVICE BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULT OF THE EVALUATION WAS THAT THERE WAS AN INDUCTIVE FAILURE OF THE JOYSTICK CAUSING THE REPORTED COMPLAINT ISSUE.

    Description of Event or Problem · 1

    JOYSTICK INTERMITTENLY MOVES THE CHAIR WITHOUT COMMAND, ALSO THE WINDOWS (OR DRIVES) ON THE JOYSTICK WILL CHANGE JUST BY MOVING THE JOYSTICK KNOB AND THEN THE JOYSTICK WILL GO A JOYSTICK FAULT.

    Description of Event or Problem · 1

    JOYSTICK INTERMITTENTLY MOVES THE CHAIR WITHOUT COMMAND, ALSO THE WINDOWS (OR DRIVES) ON THE JOYSTICK WILL CHANGE JUST BY MOVING THE JOYSTICK KNOB AND THEN THE JOYSTICK WILL GO A JOYSTICK FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841521 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET 3GAR-CG

    Patients

    Seq Age Sex Outcome Treatment
    1