BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2671896 · Received July 26, 2012

    Report

    Report Number
    1525712-2012-01048
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Report Date
    August 3, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL PR (B)(4) ISSUED MFG REPORT #1525712-2012-01048 INDICATING THE MODEL # AS GTO-CG. THE CORRECT MODEL # IS GTQ-CG. MDR DECISION DATE: (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQ-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 11 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143151 REV H (JUL-10) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S 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 AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN 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) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQ-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 11 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143151 REV H (JUL-10) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S 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 AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN 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

    "SAW CLIENT TODAY - THE TILT POTENTIOMETER WAS READJUSTED AND CURED THE SLOW CREEP OF CHAIR. V-MEDICAL HAS TURNED FORWARD SPEED UP 100% AND CHAIR WAS LUNGING. TECH SERVICE ADVISED TO REPLACE THE JOY STICK. RIGHT MOTOR LOUD NOISE AND ADVISED REPLACEMENT. QUOTE GIVEN # (B)(4) AND PARTS SHOULD BE ORDERED. CLIENT FELT BETTER ABOUT CHAIR AND NOW DOES NOT THINK IT WILL LEAVE CLIENT STRANDED."

    Description of Event or Problem · 1

    "SAW CLIENT TODAY - THE TILT POTENTIOMETER WAS READJUSTED AND CURED THE SLOW CREEP OF CHAIR. (B)(4)-MEDICAL HAS TURNED FORWARD SPEED UP 100% AND CHAIR WAS LUNGING. TECH SERVICE ADVISED TO REPLACE THE JOY STICK. RIGHT MOTOR LOUD NOISE AND ADVISED REPLACEMENT. QUOTE GIVEN (B)(4) AND PARTS SHOULD BE ORDERED. CLIENT FELT BETTER ABOUT CHAIR AND NOW DOES NOT THINK IT WILL LEAVE CLIENT STRANDED."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other