BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2435690 · Received February 2, 2012

    Report

    Report Number
    1525712-2012-00215
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Report Date
    June 14, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL (B)(4) ISSUED MFG REPORT #1525712-2012-00215. THE ACTUATOR WAS RECEIVED FOR INSPECTION ON (B)(4), IT WAS BROKEN AS WAS STATED IN THE COMPLAINT. VISUAL INSPECTION RESULTS: THE ACTUATORS' PUSH ROD HOUSING HAD EVIDENCE OF IMPACT THE MOTOR HOUSING HAD EVIDENCE OF SCRATCHES. THE ACTUATORS' HOUSING BROKE WHERE THE MOTOR MOUNTS. FUNCTIONAL INSPECTION RESULTS: THE ACTUATOR AND MOTOR WERE HELD TOGETHER, CONNECTED TO A 24VDC POWER SOURCE, AND THEN OPERATED IN BOTH DIRECTIONS. NO DISCREPANCIES WERE OBSERVED. CONCLUSION: COMPLAINT WAS DUPLICATED AS THE ACTUATOR WAS BROKEN. IT DID WORK AS IT SHOULD WHEN HELD TOGETHER. NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-MCG, 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 CONSUMERS AGE, 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

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-MCG, (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 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

    DEALER ALLEGES TILT ACTUATOR BROKE IN HALF. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    DEALER ALLEGES TILT ACTUATOR BROKE IN HALF. NO INJURY ALLEGED.

    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