BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2030747 · Received March 22, 2011

    Report

    Report Number
    1525712-2011-00132
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1525712-2011-00132. PRODUCT WAS APPROXIMATELY 25 DAYS OLD AT TIME OF COMPLAINT. DEALER ALLEGES THE CONSUMERS MOTORS LOCKED UP. BOTH A PRELIMINARY PRODUCT EVALUATION AND A REGULATORY AFFAIRS INSPECTION/TEST WERE COMPLETED. VISUAL: DEBRIS ACCUMULATED IN THE FRICTION DISK. FUNCTIONAL: THE MOTOR CONNECTED TO A SHARK POWER MODULE IN ORDER TO VERIFY ITS OPERATION ALONG WITH A CLAMP ON METER. DRIVING THE MOTOR FROM THE SHARK POWER MODULE IMMEDIATELY ENTERING ITS 90ADC CURRENT LIMIT. THE MOTOR DID NOT ROTATE EVEN AT THE 90ADC CURRENT LIMIT. WITH THE MOTOR AND GEARBOX SEPARATED IT STILL WOULD NOT ROTATE. THE PARK BRAKE WAS REMOVED. WITH THE PARK BRAKE REMOVAL THE MOTOR ROTATED NORMALLY AND SO DID THE GEARBOX. THE PARK BRAKE WAS EVALUATED AND WITH THE PARK BRAKE LEVER IN THE RELEASED POSITION, IT IS IMPOSSIBLE TO ROTATE THE FRICTION DISK BY HAND. IT APPEARS JAMMED. ONCE DISSEMBLED THERE IS METAL DEBRIS ACCUMULATION ON THE BRAKE DISK THAT HAS RESULTED IN THREE HIGH SPOTS ON THE DISK. RESULTS ARE; THE MOTOR PARK BRAKE ASSEMBLY HAS CAUSED THIS ISSUE. DEBRIS HAS ACCUMULATED IN THE FRICTION DISK AND HAS CAUSED THE COMPLETE LOCK UP OF THE PARK BRAKE ASSEMBLY. THIS, IN TURN, CAUSES THE MOTOR TO NOT ROTATE AT ALL. THIS CONFIRMS THE COMPLIANT THAT THE MOTOR HAS LOCKED UP. NO INJURY REPORTED. THE CONSUMER ALLEGES THEIR MOTORS LOCKED UP AND THEIR CHAIR STOPPED. THE USER REMAINED SUPPORTED IN THE CHAIR. UNKNOWN IF THE BATTERIES BECAME INADVERTENTLY DISCONNECTED WHILE TRANSFERRING WITH THEIR CHAIR. THERE IS NO HISTORY TO SUGGEST A PRODUCT PROBLEM. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR A SERVICE ERROR MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION. MALFUNCTION IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    NO INJURY REPORTED. THE CONSUMER ALLEGES THEIR MOTORS LOCKED UP AND THEIR CHAIR STOPPED. THE USER REMAINED SUPPORTED IN THE CHAIR. UNKNOWN IF THE BATTERIES BECAME INADVERTENTLY DISCONNECTED WHILE TRANSVERSING WITH THEIR CHAIR. THERE IS NO HISTORY TO SUGGEST A PRODUCT PROBLEM. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME, SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR A SERVICE ERROR MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION. MALFUNCTION IS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE DEALER ALLEGES THE MOTORS LOCKED UP AND THE CHAIR STOPPED WORKING IN THE MIDDLE OF THE ROAD WITH THE CONSUMER IN THE CHAIR. NO INJURIES ARE ALLEGED.

    Description of Event or Problem · 1

    THE DEALER ALLEGES THE MOTORS LOCKED UP AND THE CHAIR STOPPED WORKING IN THE MIDDLE OF THE ROAD WITH THE CONSUMER IN THE CHAIR. NO INJURIES ARE ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE 3GTQT3

    Patients

    Seq Age Sex Outcome Treatment
    1