BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2799569 · Received October 22, 2012

    Report

    Report Number
    1525712-2012-01882
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    October 18, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 IS UNKNOWN AND AGE OF THE DEVICE IS UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1143206, 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 THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL PR (B)(4) ISSUED MFR REPORT #1525712-2012-01882 INDICATING THE MANUFACTURER AS INVACARE (B)(4). THE ACTUAL MANUFACTURER IS UNKNOWN. NOTIFICATION SENT TO ALL MANUFACTURERS OF THIS TYPE OF MEDICAL DEVICE. . (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41, SERIAL NUMBER/DATE CODE IS UNKNOWN AND AGE OF THE DEVICE IS UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1143206 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 THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT THE INDICATOR LIGHTS ON THE JOYSTICK OF HER POWERED WHEELCHAIR IS NOT WORKING PROPERLY. THE REPORTER OF THIS INCIDENT HAS BEEN CONTACTED; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED. NO INJURY.

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT THE INDICATOR LIGHTS ON THE JOYSTICK OF HER POWERED WHEELCHAIR IS NOT WORKING PROPERLY. THE REPORTER OF THIS INCIDENT HAS BEEN CONTACTED HOWEVER NO FURTHER INFORMATION HAS BEEN RECEIVED. NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other