BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2401860 · Received January 6, 2012

    Report

    Report Number
    1525712-2012-00037
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    November 23, 2011
    Report Date
    March 5, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL (B)(4) ISSUED MFG REPORT #1525712-2012-00037. DEVICE COMPONENT, SEAT CUSHION, MODEL #1166142 WAS RETURNED FOR AN EVALUATION. NO PROBLEM WAS FOUND WITH THE CUSHION. THE SEAT BACK PAN WAS NOT RETURNED FOR AN EVALUATION SO THE COMPLAINT COULD NOT BE VERIFIED. PRODUCT RETURN IS NOT EXPECTED. OPERATOR'S GUIDE HAS INSTRUCTIONS ON THE PROPER AND SAFE USE OF THE PRODUCT. (B)(4) - ADDITIONAL INFORMATION - THE CONSUMER IS AN AMPUTEE. THE CONSUMER HAS HAD THE CHAIR FOR LESS THAN A YEAR. WE AGREED TO RETURN AND REPLACE THE BACK CUSHION. THE RMA NUMBER IS (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQ3 SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 MONTHS OLD. THE USER MANUAL PART NUMBER 1143151 REV I (MAY-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 CONSUMER IS A (B)(6) MALE OF UNKNOWN HEIGHT (B)(6). 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 3GTQ3 SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 MONTHS OLD. THE USER MANUAL PART NUMBER 1143151 REV I (MAY-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 IS A (B)(6) MALE OF UNKNOWN HEIGHT WHO WEIGHS (B)(6). 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 BACK FOAM DOES NOT MEET THE BOTTOM OF THE BACK, CAUSING SKIN BREAKDOWN. NO SERIOUS INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE BACK FOAM DOES NOT MEET THE BOTTOM OF THE BACK, CAUSING SKIN BREAKDOWN. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQ3

    Patients

    Seq Age Sex Outcome Treatment
    1 65 DA Other