BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 4905227 · Received July 10, 2015

    Report

    Report Number
    3008262382-2015-01477
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 29, 2015
    Manufacturer
    INVACARE REHABILITATION EQUIPMENT CO.
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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

    (B)(4). EXPANDED EVALUATION REPORT RECEIVED 7.29.2015. THE CAUSE OF MECHANICALLY WEAK BRAKE COULD NOT BE DETERMINED. ONE POSSIBLE CAUSE COULD BE A LAYER OF THE BRAKE COIL BEING SLIGHTLY OUT OF SPECIFICATION, CAUSING AN ERROR IN THE SPACING OF COMPONENTS. CONCLUSIONS: UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS "AS RECEIVED" CONDITION, THE COMPLAINT WAS CONFIRMED FOR THE 1134124 RIGHT MOTOR ASSEMBLY BRAKE TO NOT ENGAGE FULLY. THE ELECTRICAL SYSTEM ENGAGES THE BRAKE PROPERLY, BUT WHEN ENGAGED THE BRAKE WAS NOT STRONG ENOUGH TO ADEQUATELY HOLD THE MOTOR SHAFT STATIONARY.

    Description of Event or Problem · 1

    PROVIDER STATES THE RIGHT MOTOR BRAKE WILL NOT ENGAGE, OUT OF BOX.

    Description of Event or Problem · 1

    PROVIDER STATES THE RIGHT MOTOR BRAKE WILL NOT ENGAGE, OUT OF BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449004 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE REHABILITATION EQUIPMENT CO. M41SRR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other