BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2662800 · Received July 20, 2012

    Report

    Report Number
    1525712-2012-01016
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Report Date
    July 19, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    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

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-MCG, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 3 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1143190 REV G, 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. 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. THIS COMPLAINT WAS REVIEWED UNDER RISK ANALYSIS (B)(4), IN WHICH THE INTERNAL COMPONENT FAILURE RESULTING IN SIGNIFICANT PCB DAMAGE AND ASSOCIATED SMOKING. RISK ANALYSIS (B)(4) INVOLVES THE MK6 IAD PCB. THE FOUR MODULES INVOLVED WITH THE MK6 IAD PCB FAILURE ARE: GTAM - 1140037, EIAM - 1140036, TRAM - 1140098 AND CG TILT - 1151960. THE HAZARDS ASSOCIATED WITH THIS MALFUNCTION ARE: UNINTENDED CHAIR MOVEMENT, FIRE AND SMOKE INHALATION. THE SEVERITIES OF THESE HAZARDS ARE MEDIUM AND THE PROBABILITY OF OCCURRENCE WAS LOW. THIS HAZARD WAS DEEMED ACCEPTABLE BY THE RISK ANALYSIS PERFORMED PER (B)(4) RISK ASSESSMENT MATRIX. (B)(4) 2010 WAS IMPLEMENTED TO ADDRESS THE PROBLEM.

    Description of Event or Problem · 1

    "DEALER ALLEGES CHAIR HAS TILT/RECLINE/LEGS AND THE TILT AND RECLINE FUNCTIONS ARE NOT WORKING. CHECKED PROGRAMMING AND IT WAS SETUP CORRECTLY, SO CHECKED VOLTAGE ON TRAM MODULE AND THERE WAS NO VOLTAGE ON THE CONNECTIONS. ADVISED TO REPLACE TRAM MODULE. NO PARTS BEING REPLACED TODAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other