BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2355497 · Received December 1, 2011

    Report

    Report Number
    1525712-2011-00992
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Report Date
    February 28, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INITIAL PR (B)(4)ISSUED MFG REPORT #1525712-2011-00992. JOYSTICK, MODEL #1136938, SERIAL #(B)(4) WAS RETURNED FOR AN EVALUATION. WHITE PAINT WAS ON THE JOYSTICK IN SEVERAL PLACES. THE INDUCTIVE BOOT HAD DIRT AND DEBRIS IN THE CREVASSES. THE PHONO JACKS USED TO OPERATE THE TILT AND ELEVATE ACTUATORS HAD A FOREIGN RESIDUE. A FOREIGN SUBSTANCE INSIDE THE JOYSTICK (E.G. LIQUID OR OTHER CONDUCTIVE MATERIAL) COULD CAUSE UNPREDICTABLE COMMANDS FROM THE JOYSTICK. THIS CONDITION MIGHT BE RESOLVED BY THE DRYING OUT OF THE COMPONENTS OVER TIME. THE JOYSTICK WAS FUNCTIONALLY TESTED AND NO DISCREPANCIES WERE OBSERVED. RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 4 MONTHS OLD. THE USER MANUAL PART NUMBER 1143190 REV K (MAR-11) WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. 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 CONSUMER IS A (B)(6) FEMALE WHOSE HEIGHT AND WEIGHT 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) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-CG, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 4 MONTHS OLD. THE USER MANUAL PART NUMBER 1143190 (B)(4) WAS ISSUED WITH THIS DEVICE. (B)(4). 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 CONSUMER IS A (B)(6) FEMALE WHOSE 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

    DEALER ALLEGES THAT THE CONSUMER WAS USING THE CHAIR, AND WHEN THEY PRESSED THE POWER SEATING BUTTON ON THE JOYSTICK, THE CHAIR WOULD AUTOMATICALLY TILT WITHOUT ANY COMMAND ON THE JOYSTICK. INJURY IS ALLEGED.

    Description of Event or Problem · 1

    DEALER ALLEGES THAT THE CONSUMER WAS USING THE CHAIR, AND WHEN THEY PRESSED THE POWER SEATING BUTTON ON THE JOYSTICK, THE CHAIR WOULD AUTOMATICALLY TILT WITHOUT ANY COMMAND ON THE JOYSTICK. INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 DA Other