BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2397744 · Received January 4, 2012

    Report

    Report Number
    1525712-2012-00018
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    December 1, 2010
    Report Date
    January 4, 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

    (B)(4) - RETROSPECTIVE REVIEW OF THIS FILE BASED ON PROTOCOL (B)(4) DETERMINED THIS IS AN MDR. RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-MCG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THE USER MANUAL PART NUMBER 1143190 REV J (NOV-10) 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

    (B)(4) - THE PRODUCT WAS 3 MONTHS OLD AT TIME OF COMPLAINT. CONSUMER ALLEGES THAT CHAIR VEERS TO RIGHT. DEALER ALLEGES INSTALLING NEW STABILITY LOCK CYLINDER, BUT WHEN TEST DROVE HAD SIMILAR ISSUE. PRODUCT RETURNED FOR REGULATORY AFFAIRS INSPECTION ON RMA # (B)(4). VISUAL: THE TILT ACTUATOR HARNESS WAS LYING BETWEEN THE LEFT DRIVE WHEEL AND THE FRAME OF THE CHAIR BASE. THE CHAIR BASE'S LEFT DRIVE WHEEL WAS NOT MAKING CONTACT WITH THE GROUND AND THE LEFT STABILITY LOCK ACTUATOR WAS NOT ENGAGING WITH THE STOP. THE CHAIR BASE'S FRONT CATERS HAD EVIDENCE OF SCRATCHES AND THE LEFT REAR CASTER HEAD TUBE HAD EVIDENCE OF IMPACT. FUNCTIONAL: THE CHAIR BASE WAS TESTED IN ALL FOUR DRIVES. NO DISCREPANCIES WERE OBSERVED. THE ALLEGED CLAIM COULD NOT BE DUPLICATED. (B)(4). RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-MCG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THE USER MANUAL PART NUMBER 1143190 REV J (NOV-10) 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.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE CHAIR VEERS TO THE RIGHT. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE CHAIR VEERS TO THE RIGHT. 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-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other