BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2325925 · Received November 7, 2011

    Report

    Report Number
    1525712-2011-00769
    Event Type
    Malfunction
    Date Received
    November 7, 2011
    Date of Event
    October 11, 2011
    Report Date
    March 20, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INITIAL PR (B)(4) ISSUED MFG REPORT #1525712-2011-00769. THE DEVICE, MODEL #TDXSP-MCG, SERIAL #(B)(4), COMPONENTS, JOYSTICK, MODEL #1136887, SERIAL #(B)(4), CONTROLLER, MODEL #1136898 REV E, SERIAL #(B)(4), K6 SWITCH, MODEL #1036903, SERIAL #(B)(4), 4-WAY SWITCH, MODEL #1080116 AND MK6 TRAM, MODEL #1140098, SERIAL #(B)(4) WERE RETURNED FOR AN EVALUATION. CHAIR WAS APPROXIMATELY 3 YEARS OLD AT THE TIME OF INCIDENT. EXTERNAL INSPECTION REVEALED NO VISIBLE DAMAGE. INTERNAL INSPECTION REVEALED HEAT DAMAGE. OVERHEATING OF THE PCB AND COMPONENTS IN THE AREA OF THE OUTPUT FETS OCCURRED. THIS FAILURE IS COVERED UNDER RISK ASSESSMENT 119. DESIGN IS VIEWED AS ALARP. SOME DEGREE OF SMOKING LIKELY OCCURRED; HOWEVER, THIS WAS NOT AN INDICATION OF SUSTAINED COMBUSTION. THE ELECTRONIC MALFUNCTION OF THE CONTROLLER, INCLUDING ANY DEBRIS THAT RESULTED, WAS CONTAINED WITHIN THE METAL ENCLOSURE OF THE DEVICE. THE CABLES SHOWED NO SIGNS OF OVERHEATING. AN ECN WAS IMPLEMENTED THAT UPDATED THE SOFTWARE WHICH CHANGED MOTOR CONTROL TO ELIMINATE REGENERATIVE MOTOR CURRENTS FROM REVERSING AND CAUSING COMPONENT DAMAGE. QUOTE NUMBER: (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-MCGSERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 3 YEARS OF AGE. THE USER MANUAL PART NUMBER 1143190 WAS ISSUED WITH THIS DEVICE. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER IS (B)(6), HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    QUOTE NUMBER: (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-MCG SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 3 YEARS OF AGE. THE USER MANUAL PART NUMBER (B)(4) WAS ISSUED WITH THIS DEVICE. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMERS IS (B)(6), HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    CONSUMER ALLEGEDLY SAW AND SMELLED SMOKE FROM THE RIGHT SIDE OF THE POWER CHAIR. CHAIR ALLEGEDLY DID NOT OPERATE AND WAS ALLEGEDLY STUCK IN THE TILT POSITION. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CONSUMER ALLEGEDLY SAW AND SMELLED SMOKE FROM THE RIGHT SIDE OF THE POWER CHAIR. CHAIR ALLEGEDLY DID NOT OPERATE AND WAS ALLEGEDLY STUCK IN THE TILT POSITION. NO INJURY ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 DA Other