BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2433983 · Received February 1, 2012

    Report

    Report Number
    1525712-2012-00208
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Report Date
    June 2, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-CG, (B)(4) IS APPROXIMATELY 5 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-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 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. (B)(4) - RESULTS OF INSPECTION: VISUAL: THE ACTUATOR'S PISTON ROD HOUSING HAD EVIDENCE OF SCRATCHES. FUNCTIONAL: THE ACTUATOR WAS CONNECTED TO A 24VDC POWER SOURCE AND THEN OPERATED. THE ACTUATOR MOTOR WOULD RUN BUT THE PISTON DID NOT MOVE. THE ACTUATOR AND THE MOTOR WERE SEPARATED AND THEN OPERATED. THE ACTUATOR OPERATED WITHOUT FAILURE. THE PISTON WOULD NOT OPERATE. CONCLUSION: WAS ABLE TO DUPLICATE FAILURE.

    Description of Event or Problem · 1

    CONSUMER HEARD A POP AND THE TILT ALLEGEDLY DROPPED WITH HIM IN IT, THE TILT RUNS, BUT ALLEGEDLY DOES NOT TILT. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    CONSUMER HEARD A POP AND THE TILT ALLEGEDLY DROPPED WITH HIM IN IT, THE TILT RUNS, BUT ALLEGEDLY DOES NOT TILT. NO 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 Other