BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M51P BLUE BASE W/MK5 NX SPJ+ 9153642087

    MDR report key: 5263198 · Received December 3, 2015

    Report

    Report Number
    3008262382-2015-01990
    Event Type
    Malfunction
    Date Received
    December 3, 2015
    Report Date
    November 10, 2015
    Manufacturer
    INVACARE REHABILITATION EQUIPMENT CO.
    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 LEFT MOTOR/GEARBOX ASSEMBLY WAS RETURNED FOR EVALUATION, AND SUBSEQUENT TESTING VERIFIED THE COMPLAINT. PER THE INITIAL RETURN EVALUATION, THE BRAKE WIRE WAS MELTED TO THE BRUSH SHUNT CAUSING AN ELECTRICAL BRAKE FAILURE WITH AN ERROR CODE AND CAUSING THE MOTOR TO SMELL HOT. PER THE EXPANDED EVALUATION REPORT, THERE WAS DISCOLORATION TO THE BRUSH SHUNT AND INSULATION OF THE BRAKE WIRE. WHEN THE MOTOR WAS MANEUVERED NEAR THE STRAIN RELIEF, THERE WAS A FIVE FLASH ERROR CODE INDICATING A LEFT PARK BRAKE FAULT.

    Description of Event or Problem · 1

    DEALER ADVISED END USER STATED SHE WAS IN CHAIR WHILE BEING TRANSPORTED IN A VAN AND SMELT SMOKE AND BURNING AND THOUGHT IT WAS COMING FROM THE CHAIR. SPOKE WITH TECH. DEALER ADVISED DID A LOAD TEST AND NOW GETTING SIX FLASH ERROR CODE. TECH ADVISED LEFT MOTOR IS THE ISSUE, PART 1163476. DEALER COULD NOT CONFIRM SMOKE OR BURNING RECEIVED INFORMATION FROM TECH DUE TO SPEAKING WITH DEALER AND DEALER PHONE DISCONNECTED. THE DEALER CALLED BACK AND VERIFIED THAT THE SMELL OF SMOKE AND BURNING WERE BY THE LEFT MOTOR. THE LEFT MOTOR/GEARBOX ASSEMBLY WAS RETURNED FOR EVALUATION, AND SUBSEQUENT TESTING VERIFIED THE COMPLAINT. PER THE INITIAL RETURN EVALUATION, THE BRAKE WIRE WAS MELTED TO THE BRUSH SHUNT CAUSING AN ELECTRICAL BRAKE FAILURE WITH AN ERROR CODE AND CAUSING THE MOTOR TO SMELL HOT. PER THE EXPANDED EVALUATION REPORT, THERE WAS DISCOLORATION TO THE BRUSH SHUNT AND INSULATION OF THE BRAKE WIRE. WHEN THE MOTOR WAS MANEUVERED NEAR THE STRAIN RELIEF, THERE WAS A FIVE FLASH ERROR CODE INDICATING A LEFT PARK BRAKE FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796217 M51P BLUE BASE W/MK5 NX SPJ+ 9153642087 WHEELCHAIR, POWERED ITI INVACARE REHABILITATION EQUIPMENT CO. M51PSEMIBLUE

    Patients

    Seq Age Sex Outcome Treatment
    1