BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 5233712 · Received November 18, 2015

    Report

    Report Number
    3008262382-2015-01957
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Report Date
    November 18, 2015
    Manufacturer
    INVACARE REHABILITATION EQUIPMENT CO.
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: CONSUMER POWER WHEELCHAIRS. MOTOR, BRAKE FAILURE - ELECTRICAL. ELECTRICAL BRAKE FAILURE - BENCH TEST. WIGGLE WIRES BY THE STRAIN RELIEF AND IT WILL SHUT OFF AND GIVE A BRAKE FAULT DURING BENCH TEST. PRODUCT RECEIVED EXPANDED EVALUATION. THE EXPANDED EVALUATION REPORT STATES: UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS "AS RECEIVED" CONDITION, THE COMPLAINT WAS CONFIRMED FOR THE LEFT MOTOR AND GEARBOX OF HAVING A BRAKE FAULT CAUSED BY A BAD CONNECTION NEAR THE STRAIN RELIEF. COMPLAINT WAS CONFIRMED. THE UNDERLYING CAUSE IS BAD CONNECTION NEAR THE STRAIN RELIEF.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: CONSUMER POWER WHEELCHAIRS. MOTOR, BRAKE FAILURE - ELECTRICAL. ELECTRICAL BRAKE FAILURE - BENCH TEST. WIGGLE WIRES BY THE STRAIN RELIEF AND IT WILL SHUT OFF AND GIVE A BRAKE FAULT DURING BENCH TEST. PRODUCT RECEIVED EXPANDED EVALUATION. THE EXPANDED EVALUATION REPORT STATES: UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS "AS RECEIVED" CONDITION, THE COMPLAINT WAS CONFIRMED FOR THE LEFT MOTOR AND GEARBOX OF HAVING A BRAKE FAULT CAUSED BY A BAD CONNECTION NEAR THE STRAIN RELIEF. DEALER IS STATING THAT THE MOTOR LEAD IS LOOSE, AND EVERYTIME IT MOVES THE MOTOR SHUTS DOWN.

    Description of Event or Problem · 1

    DEALER IS STATING THAT THE MOTOR LEAD IS LOOSE, AND EVERYTIME IT MOVES, THE MOTOR SHUTS DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762289 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE REHABILITATION EQUIPMENT CO. M51PSEMIRED

    Patients

    Seq Age Sex Outcome Treatment
    1