BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2843201 · Received November 21, 2012

    Report

    Report Number
    3004493922-2012-00507
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 20, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS, 5 MONTHS OLD.THE OWNER'S MANUAL PART NUMBER 1143206, REV.G(FEB-09) 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. THE CONSUMER WAS CONTACTED FOR ADDTIONAL DETAIL. NO FURTHER INFORMATION WAS RECEIVED ON 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

    CONSUMER ALLEGES A FACILITY ADVISOR AT THE NURSING HOME WENT TO PLUG IN HER WHEELCHAIR AND THE POWER CHAIR SPARKED WHERE THE CONTROLLER IS. THE REPORTER WAS CONTACTED AND IT WAS LEARNED THAT THE POWER CHAIR SPARKED AFTER PLUGGING IT UP TO BE CHARGED. NO INJURY BUT THE POWER CHAIR WILL NO LONGER WORK. IF ANY FURTHER DETAIL IS OBTAINED THE NEW INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. THE END USER WAS REFERRED TO A LOCAL DEALER FOR FURTHER EVALUATION AND OR REPAIR OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41

    Patients

    Seq Age Sex Outcome Treatment
    1 67 Other