BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2843134 · Received November 21, 2012

    Report

    Report Number
    1525712-2012-02289
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    November 20, 2012
    Manufacturer
    UNKNOWN
    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

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M51 SERIAL NUMBER/DATE CODE 05F23385 IS APPROXIMATELY 7 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1125085, REV.J (OCT-08) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. NO FURTHER INFORMATION HAS BEEN RECEIVED. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    THE DEALER ALLEGED THAT THE END USER WAS DRIVING THE CHAIR, THE LEFT DRIVE WHEEL CAME OFF THE GEARBOX. DEALER ALSO ALLEGED THAT SOMEONE BEFORE THEM HAD INSTALLED THEIR OWN NUT AND BOLT TO SECURE THE WHEEL. IN SPEAKING WITH THE REPORTER OF THIS INCIDENT IT WAS LEARNED NO INJURY HAD OCCURRED TO THE USER OF THE CHAIR. IF ANY FURTHER INFORMATION IS RECEIVED ON THIS INCIDENT, NEW INFORMATION WILL BE PROVIDED IN THE FOLLOW UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other