BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2305621 · Received October 24, 2011

    Report

    Report Number
    1525712-2011-00607
    Event Type
    Malfunction
    Date Received
    October 24, 2011
    Date of Event
    September 22, 2011
    Report Date
    February 28, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MK6 GTAM BOX, MODEL #1140037, SERIAL # (B)(4) AND THE TILT ACTUATOR, MODEL #73464, SERIAL # (B)(4) WERE RETURNED FOR AN EVALUATION. THE CHAIR WAS APPROXIMATELY 3 YEARS OLD AT TIME OF INCIDENT. EXTERNAL INSPECTION REVEALED HEAT DAMAGE TO THE CONNECTOR. INTERNAL INSPECTION REVEALED HEAT DAMAGE. OVERHEATING OF THE PCB AND COMPONENTS IN THE AREA OF THE OUTPUT FETS OCCURRED. THIS FAILURE IS COVERED UNDER (B)(4). DESIGN IS VIEWED AS (B)(4). THE CABLES SHOWED NO SIGNS OF OVERHEATING. AN (B)(4) WAS IMPLEMENTED THAT UPDATED THE SOFTWARE WHICH CHANGED MOTOR CONTROL TO ELIMINATE REGENERATIVE MOTOR CURRENTS FROM REVERSING AND CAUSING COMPONENT DAMAGE. (B)(4) HAS BEEN GENERATED FOR THIS ISSUE. MODEL TDXSP-CG, SERIAL NUMBER (B)(4) IS APPROXIMATELY 3 YEARS AND 4 MONTHS OLD. USER MANUAL PART NUMBER 1143190 REV F (APR-08) WAS ISSUED FOR THIS DEVICE. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USERS MANUAL. THE FOLLOWING WARNING IS PROVIDED ON PAGE 2: "WHEELCHAIR USERS: DO NOT SERVICE OR OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THE OWNER'S OPERATOR AND MAINTENANCE MANUAL AND THE SEATING SYSTEM'S MANUAL (IF APPLICABLE). IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS, AND INSTRUCTIONS, CONTACT INVACARE TECHNICAL SUPPORT BEFORE ATTEMPTING TO SERVICE OR OPERATE THIS EQUIPMENT - OTHERWISE INJURY OR DAMAGE MAY RESULT." THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S AGE IS (B)(6), HEIGHT IS UNKNOWN AND WEIGHT IS (B)(6). IT IS UNKNOWN IF THE CONSUMER IS A SMOKER OR IS EXPOSED TO OPEN FLAMES, FIREWORKS, CANDLES, FIREPLACES, SPACE HEATERS, ETC. THE FOLLOWING WARNING IS PROVIDED ON PAGE 16: "AVOID STORING OR USING THE WHEELCHAIR NEAR OPEN FLAME OR COMBUSTIBLE PRODUCTS. SERIOUS INJURY OR DAMAGE TO PROPERTY MAY RESULT."

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN GENERATED FOR THIS ISSUE. MODEL TDXSP-CG SERIAL NUMBER (B)(4) IS APPROXIMATELY 3 YEARS AND 4 MONTHS OLD. USER MANUAL PART NUMBER 1143190 REV F (APR-08) WAS ISSUED FOR THIS DEVICE. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USERS MANUAL. THE FOLLOWING WARNING IS PROVIDED ON PAGE 2: "WHEELCHAIR USERS: DO NOT SERVICE OR OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THE OWNER'S OPERATOR AND MAINTENANCE MANUAL AND THE SEATING SYSTEM'S MANUAL (IF APPLICABLE). IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS, AND INSTRUCTIONS, CONTACT INVACARE TECHNICAL SUPPORT BEFORE ATTEMPTING TO SERVICE OR OPERATE THIS EQUIPMENT - OTHERWISE INJURY OR DAMAGE MAY RESULT." THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS AGE IS (B)(6), HEIGHT IS UNKNOWN AND WEIGHT IS (B)(6). IT IS UNKNOWN IF THE CONSUMER IS A SMOKER OR IS EXPOSED TO OPEN FLAMES, FIREWORKS, CANDLES, FIREPLACES, SPACE HEATERS, ETC.. THE FOLLOWING WARNING IS PROVIDED ON PAGE 16: "AVOID STORING OR USING THE WHEELCHAIR NEAR OPEN FLAME OR COMBUSTIBLE PRODUCTS. SERIOUS INJURY OR DAMAGE TO PROPERTY MAY RESULT."

    Description of Event or Problem · 1

    UNIT(S) ALLEGEDLY MELTED. CONSUMER STATED THAT THEY HEARD CRACKLING. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    UNIT(S) ALLEGEDLY MELTED. CONSUMER STATED THAT THEY HEARD CRACKLING. 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 57 DA Other