BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2652772 · Received July 12, 2012

    Report

    Report Number
    3004493922-2012-00222
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Report Date
    October 3, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR REPORT #3004493922-2012-00222 WITH THE MANUFACTURER AS INVACARE (B)(4). THE CORRECT MANUFACTURER IS INVACARE (B)(4). (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41SR20B, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR AND 1 MONTH 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 CONSUMERS' AGE, HEIGHT, AND WEIGHT ARE UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MODEL M41SR20B, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR AND 1 MONTH 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'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. 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.

    Description of Event or Problem · 1

    DEALER STATES "BATTERY CHARGER STARTED SMOKING AND SMELLED OF FIRE." (B)(4). NO INJURY ALLEGED.

    Description of Event or Problem · 1

    DEALER STATES "BATTERY CHARGER STARTED SMOKING AND SMELLED OF FIRE." RMA # (B)(4). NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SR20B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other