BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2243368 · Received September 12, 2011

    Report

    Report Number
    1525712-2011-00501
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 12, 2011
    Report Date
    September 9, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. THIS TDXSP HAS OWNERS MANUAL PART NO 1143190 REV G - 01/09. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNERS MANUAL. THE FOLLOWING WARNING IS PROVIDED ON PAGE 11 - WARNING: "DO NOT USE THIS PRODUCT OR ANY AVAILABLE OPTIONAL EQUIPMENT WITHOUT FIRST COMPLETELY READING AND UNDERSTANDING THESE INSTRUCTIONS AND ANY ADDITIONAL INSTRUCTIONAL MATERIAL SUCH AS OWNER'S MANUALS, SERVICE MANUALS OR INSTRUCTION SHEETS SUPPLIED WITH THIS PRODUCT OR OPTIONAL EQUIPMENT. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR. PROCEDURES OTHER THAN THOSE DESCRIBED IN THIS MANUAL MUST BE PERFORMED BY A QUALIFIED TECHNICIAN." IT IS UNKNOWN IF THE CONSUMER HAS ATTEMPTED TO MAKE ADJUSTMENTS TO THE WHEEL CHAIR ON THEIR OWN. PAGE 12 PROVIDES THE FOLLOWING WARNING FOR SET UP: "A QUALIFIED TECHNICIAN MUST PERFORM THE INITIAL SET UP OF THIS WHEELCHAIR. ALSO, A QUALIFIED TECHNICIAN MUST PERFORM ALL PROCEDURES IN THE SERVICE MANUAL. PERFORMANCE ADJUSTMENTS SHOULD ONLY BE MADE BY PROFESSIONALS OF THE HEALTHCARE FIELD OR PERSONS FULLY CONVERSANT WITH THIS PROCESS AND THE DRIVER'S CAPABILITIES. INCORRECT SETTINGS COULD CAUSE INJURY TO THE DRIVER, BYSTANDERS, DAMAGE TO THE WHEELCHAIR AND TO SURROUNDING PROPERTY. AFTER THE WHEELCHAIR HAS BEEN SET-UP/ADJUSTED, CHECK TO MAKE SURE THAT THE WHEELCHAIR PERFORMS TO THE SPECIFICATIONS ENTERED DURING THE SET-UP PROCEDURE. IF THE WHEELCHAIR DOES NOT PERFORM TO SPECIFICATIONS, TURN THE WHEELCHAIR OFF IMMEDIATELY AND REENTER SET-UP SPECIFICATIONS. REPEAT THIS PROCEDURE UNTIL THE WHEELCHAIR PERFORMS TO SPECIFICATIONS." THE MAINTENANCE HISTORY ON THIS DEVICE IS UNKNOWN. THE FOLLOWING WARNING IS PROVIDED ON PAGE 15 FOR MAINTENANCE: REPAIR OR SERVICE INFORMATION: 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." DEALERS AND QUALIFIED TECHNICIANS: "DO NOT SERVICE OR OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THE OWNER'S OPERATOR AND MAINTENANCE MANUAL, THE SERVICE MANUAL (IF APPLICABLE) 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. SET-UP OF THE ELECTRONICS CONTROL UNIT IS TO BE PERFORMED ONLY BY A QUALIFIED TECHNICIAN. THE FINAL ADJUSTMENTS OF THE CONTROLLER MAY AFFECT OTHER ACTIVITIES OF THE WHEELCHAIR. DAMAGE TO THE EQUIPMENT COULD OCCUR IF IMPROPERLY SET-UP OR ADJUSTED. EXCEPT FOR PROGRAMMING," "DO NOT SERVICE OR ADJUST THE WHEELCHAIR WHILE OCCUPIED, UNLESS OTHERWISE NOTED. BEFORE ADJUSTING, REPAIRING OR SERVICING THE WHEELCHAIR, ALWAYS TURN THE WHEELCHAIR POWER OFF, OTHERWISE, INJURY OR DAMAGE MAY OCCUR. WHEELCHAIRS SHOULD BE EXAMINED DURING MAINTENANCE FOR SIGNS OF CORROSION (WATER EXPOSURE, INCONTINENCE, ETC.). ELECTRICAL COMPONENTS DAMAGED BY CORROSION SHOULD BE REPLACED IMMEDIATELY. WHEELCHAIRS THAT ARE USED BY INCONTINENT USERS AND/OR ARE FREQUENTLY EXPOSED TO WATER MAY REQUIRE REPLACEMENT OF ELECTRICAL COMPONENTS MORE FREQUENTLY." "DO NOT OVER TIGHTEN HARDWARE ATTACHING TO THE FRAME. THIS COULD CAUSE DAMAGE TO THE FRAME TUBING. TRANSPORT READY PACKAGES ARE NOT RETROFITTABLE TO EXISTING MODELS AND ARE NOT FIELD SERVICEABLE. FOR OPTIMAL PERFORMANCE, REPLACE GAS-LOCKING CYLINDERS EVERY TWO YEARS OR IF PERFORMANCE ISSUES ARE ENCOUNTERED. PERFORMANCE ISSUES INCLUDE FORWARD TIPPING AND VEERING." IT IS UNKNOWN IF THE CONSUMER HAS MADE ADJUSTMENTS TO THE CONTROLLER. INCORRECTLY ADJUSTING THE CONTROLLER AFFECTS THE WHEEL CHAIR ACTIVITIES. PAGE 39 WARNING [WHEEL CHAIR OPERATION]: "AFTER ANY ADJUSTMENTS, REPAIR OR SERVICE AND BEFORE USE, MAKE SURE THAT ALL ATTACHING HARDWARE IS TIGHTENED SECURELY - OTHERWISE INJURY OR DAMAGE MAY RESULT. SET-UP OF THE ELECTRONIC CONTROL UNIT IS TO BE PERFORMED ONLY BY A QUALIFIED TECHNICIAN. THE FINAL ADJUSTMENTS OF THE CONTROLLER MAY AFFECT OTHER ACTIVITIES OF THE WHEELCHAIR. DAMAGE TO THE EQUIPMENT COULD OCCUR UNDER THESE CIRCUMSTANCES."

    Description of Event or Problem · 1

    THE CONSUMER HAS ALLEGEDLY HAD THREE MOTORS REPLACED WITHIN A YEAR AND A HALF OF PURCHASING THE PRODUCT. THE CONSUMER HAS ALSO ALLEGEDLY HAS ISSUES WITH THE ARMRESTS, RETRACTABLE JOYSTICK, THE ARM, AND TILT ACTUATOR. NO DETAILS HAVE BEEN PROVIDED ON A SPECIFIC ALLEGED INCIDENT. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TDXSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other