BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2451994 · Received February 15, 2012

    Report

    Report Number
    1525712-2012-00259
    Event Type
    Malfunction
    Date Received
    February 15, 2012
    Report Date
    February 14, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL PR (B)(4) ISSUED MFG REPORT #1525712-2012-00259. THE DEVICE WAS ABOUT 2 MONTHS OLD AT THE TIME OF THE COMPLAINT. CUSTOMER ALLEGES DURING DEMONSTRATION OF TILTING THE CHAIR, ALLEGEDLY HEARD A POPPING NOISE AND THE TILT NO LONGER WORKED. ACTUATOR WAS RETURNED FOR AN EVALUATION. FINDINGS: ACTUATOR WAS CONNECTED TO A 24VDC POWER SUPPLY. ACTUATOR'S MOTOR OPERATED BUT ACTUATOR ROD END WOULD NOT MOVE. EVALUATION DID NOT CONCLUDE WHY THE ROD DID NOT MOVE. WARRANTY REPLACEMENT SENT OUT ON RA / ORDER # (B)(4). COMPLAINT WAS CONFIRMED. RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 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 CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S AGE, 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

    RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-CG, (B)(4) IS APPROXIMATELY 2 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 CONSUMERS AGE, 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

    DURING DEMONSTRATION OF TILTING THE CHAIR, TECH ALLEGEDLY HEARD A POPPING NOISE AND THE TILT NO LONGER WORKED. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    DURING DEMONSTRATION OF TILTING THE CHAIR, TECH ALLEGEDLY HEARD A POPPING NOISE AND THE TILT NO LONGER WORKED. NO 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