BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2230981 · Received September 1, 2011

    Report

    Report Number
    1525712-2011-00483
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    September 1, 2011
    Manufacturer
    INVACARE
    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

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THE DEVICE. THE CHAIR TESTED FINE AT THE DEALERS LOCATION. THE WHEEL CHAIR WAS TRANSPORTED TO THE INSTITUTION AND THE ELECTRONICS WERE RE-PROGRAMMED. THE TRANSPORTATION METHOD USED TO MOVE THE CHAIR FROM THE DEALERS LOCATION TO THE INSTITUTION IS UNKNOWN. IT IS UNKNOWN HOW MUCH EXPERIENCE THE DEALER HAS PROGRAMMING THE WHEEL CHAIR ELECTRONICS. WHEEL CHAIR MODEL TDXSP-CG (B)(4) IS APPROXIMATELY 1 MONTH OLD. USER MANUAL PART NUMBER 1143190 REV K (3/11) WAS PROVIDED WITH THIS DEVICE. IT IS UNKNOWN IF THE DEALER HAS FULLY READ AND UNDERSTANDS THE USER MANUAL. PAGE 11 OF THE USER MANUAL STATES: "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." THE TRANSPORTATION METHOD FOR THIS WHEEL CHAIR IS UNKNOWN. IT IS UNKNOWN IF THE WHEEL CHAIR WAS MOVED WITHOUT INCIDENT TO THE INSTITUTION. THE USER MANUAL PROVIDES THE FOLLOWING INFORMATION ON TRANSPORTATION OF THE WHEEL CHAIR: PAGE 64 WARNING FOR TRRO STATES; "THIS SECTION APPLIES ONLY TO WHEELCHAIRS EQUIPPED WITH TRRO (TRANSPORT READY OPTION). CONTACT INVACARE CORPORATION (800-333-6900) WITH ANY QUESTIONS ABOUT USING THIS WHEELCHAIR FOR SEATING IN A MOTOR VEHICLE. WHEN FEASIBLE, WHEELCHAIR OCCUPANTS SHOULD TRANSFER INTO THE VEHICLE SEAT AND USE THE OEM (ORIGINAL EQUIPMENT MANUFACTURER) VEHICLE-INSTALLED RESTRAINT SYSTEM. THIS WHEELCHAIR HAS BEEN DYNAMICALLY TESTED IN A FORWARD-FACING MODE WITH THE SPECIFIED CRASH TEST DUMMY RESTRAINED BY BOTH PELVIC AND UPPER-TORSO BELT(S) (SHOULDER BELTS), AND THAT BOTH PELVIC AND UPPER TORSO BELT(S) SHOULD BE USED TO REDUCE THE POSSIBILITY OF HEAD AND CHEST IMPACTS WITH VEHICLE COMPONENTS. USE ONLY WHEELCHAIR TIE-DOWN AND OCCUPANT RESTRAINT SYSTEMS (WTORS) WHICH MEET THE REQUIREMENTS OF THE SAE (SOCIETY OF AUTOMOTIVE ENGINEERS) J2249 RECOMMENDED PRACTICE DURING TRAVEL IN A MOTOR VEHICLE. THIS WHEELCHAIR HAS BEEN TESTED FOR SEATING IN A MOTOR VEHICLE WITH THE FACTORY INSTALLED SEATING SYSTEM ONLY. THIS WHEELCHAIR MUST BE IN A FORWARD FACING POSITION DURING TRAVEL IN A MOTOR VEHICLE. THIS WHEELCHAIR IS EQUIPPED, AND HAS BEEN DYNAMICALLY TESTED TO RELY ON WHEELCHAIR-ANCHORED PELVIC BELTS. IF DESIRED, VEHICLE-ANCHORED PELVIC BELTS MAY BE USED. IT IS STRONGLY RECOMMENDED THAT BOTH PELVIC AND UPPER-TORSO BELT(S) BE USED TO REDUCE THE RISK OF INJURY. TO REDUCE THE POTENTIAL OF INJURY TO VEHICLE OCCUPANTS, WHEELCHAIR-MOUNTED ACCESSORIES, INCLUDING BUT NOT LIMITED TO IV POLES, TRAYS, RESPIRATORY EQUIPMENT, BACKPACKS, AND OTHER PERSONAL ITEMS SHOULD BE REMOVED AND SECURED SEPARATELY. POSTURAL SUPPORTS, POSITIONING DEVICES, AND/OR STRAP(S) SHOULD NOT BE RELIED ON FOR OCCUPANT RESTRAINT. THESE ITEMS MAY BE USED IN ADDITION TO THE WHEELCHAIR-ANCHORED OR VEHICLE-ANCHORED BELTS." FURTHER WARNINGS ON THE TRANSPORTING OF THE WHEEL CHAIR ARE PROVIDED ON PAGE 65. IT IS UNKNOWN IF THE DEALER FOLLOWED THIS WARNING: PAGE 65 WARNING [SEAT ANGLE - COLLISION WITH OTHER STRUCTURES] - "SEAT ANGLE IS FACTORY SET AT TIME OF SHIPMENT. ADJUSTMENTS TO THE WHEELCHAIR MAY VOID WC 19 COMPLIANCE. TO MAINTAIN COMPLIANCE, REFER TO WHEELCHAIR SERVICE MANUAL BEFORE MAKING ANY ADJUSTMENTS. DO NOT ALTER OR SUBSTITUTE WHEELCHAIR FRAME PARTS, COMPONENTS, OR SEATING SYSTEMS. A SUDDEN STOP AND/OR COLLISION MAY STRUCTURALLY DAMAGE YOUR WHEELCHAIR. WHEELCHAIRS INVOLVED IN SUCH INCIDENTS SHOULD BE REPLACED. SPILL PROOF BATTERIES, SUCH AS "GEL CELLS", SHOULD BE INSTALLED ON WHEELCHAIRS TO BE USED DURING TRAVEL IN A MOTOR VEHICLE. TRANSPORT READY PACKAGES ARE NOT A RETROFIT TO EXISTING MODELS AND ARE NOT FIELD SERVICEABLE." IT IS UNKNOWN IF THE DEALER PROGRAMMED THE ELECTRONICS PROPERLY AND FOLLOWED THE WARNING ON PAGE 39 BELOW. PAGE 39 WARNING [WHEEL CHAIR ELECTRONIC CONTROL BOX] - "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

    WHILE THE DEALER WAS PROGRAMMING THE ELECTRONICS ON THE NEW CHAIR, HE ALLEGEDLY SMELLED SMOKE AND HE NOTICED SMOKE COMING FROM THE ROUND PART OF THE SANODE. THE DEALER REPLACED THE SANODE AND THE CHAIR APPEARS TO BE WORKING FINE. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other