BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2471805 · Received February 29, 2012

    Report

    Report Number
    1525712-2012-00298
    Event Type
    Malfunction
    Date Received
    February 29, 2012
    Report Date
    April 11, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-CG, (B)(4) IS APPROXIMATELY 1 YEAR 8 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143190 REV I (JUN-10) 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 IS A MALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    INITIAL (B)(4) ISSUED MFG REPORT # 1525712-2012-00298. THE COMPONENTS, MOTOR MODEL #11416888, SERIAL NUMBER (B)(4), DATE CODE (B)(4) AND CONTROLLER MODEL #1136898 REV F, SERIAL # (B)(4) HAS BEEN RETURNED FOR AN EVALUATION. THE GEARBOX SHAFT HAD A SIGNIFICANT AMOUNT OF HAIR WRAPPED AROUND IT. THE MOTOR WAS NOISY WHEN FUNCTIONALLY TESTED BUT NO OTHER DISCREPANCIES WERE OBSERVED. THE CONTROLLER WAS ALSO TESTED AND NO DISCREPANCIES WERE OBSERVED. NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR 8 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143190 REV I (JUN-10) 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 IS A MALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN 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 ALLEGES THAT THE TILT ACTUATOR STARTED TILTING BACK WHILE HE WAS UNDERNEATH THE STEERING WHEEL OF HIS VAN; HE WAS NOT DRIVING AT THAT TIME. MINOR INJURY ALLEGED.

    Description of Event or Problem · 1

    CONSUMER ALLEGES THAT THE TILT ACTUATOR STARTED TILTING BACK WHILE HE WAS UNDERNEATH THE STEERING WHEEL OF HIS VAN; HE WAS NOT DRIVING AT THAT TIME. MINOR INJURY 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 Other