BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2232464 · Received September 2, 2011

    Report

    Report Number
    1525712-2011-00481
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 30, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THE DEVICE. A REPLACEMENT UNIT HAS BEEN ORDERED FOR THE CONSUMER. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN IS UNKNOWN. INVACARE HAS NOTED THAT IN SOME CASES, CONSUMERS WITH CEREBRAL PALSY AND WITH A THE CONDITION OF HIGH TONE, HAVE CRACKED FRAMES AND CRACKED BACK CANES. EACH CONSUMER WITH MODEL SOLARA2G WHEEL CHAIR HAS BEEN GIVEN USER MANUAL 1125027. THIS DEVICE IS 2.5 YEARS OLD. THEREFORE, REV D OF THE USER MANUAL APPLIES. THE USER MANUAL WARNINGS, CAUTIONS AND INSTRUCTIONS ARE PROVIDED TO HELP PREVENT THE FRAME FROM CRACKING. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER MANUAL. ON PAGE 2 A WARNING 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." THE WEIGHT OF THE CONSUMER IS UNKNOWN. IT IS UNKNOWN IF THE CONSUMER HAS THE HEAVY DUTY PACKAGE: THE WEIGHT LIMITS ARE PROVIDED ON PAGE 11. SPREE 200 LBS, SOLARA 250 LBS., SOLARA HEAVY DUTY PACKAGE 350 LBS. IT IS UNKNOWN IF THE CONSUMER FOLLOWS THE OPERATION INFORMATION AS STATED ON PAGES 17 AND 18. FOLLOWING THESE INSTRUCTIONS MAY HAVE AVOIDED THE CRACKED FRAME. PAGE 17 - OPERATION INFORMATION: IF THE WHEELCHAIR IS EXPOSED TO EXTREME TEMPERATURE (ABOVE 100°F OR BELOW 32°F), HIGH HUMIDITY AND/OR BECOMES WET, PRIOR TO USE, ENSURE HANDGRIPS DO NOT TWIST ON THE WHEELCHAIR HANDLE - OTHERWISE DAMAGE OR INJURY MAY OCCUR. ALWAYS CHECK FOAM GRIPS FOR LOOSENESS BEFORE USING THE WHEELCHAIR. IF LOOSE, CONTACT A QUALIFIED TECHNICIAN FOR INSTRUCTIONS. THE NECESSARY BACK ANGLE (90°, 100°, 110° OR 120°) MUST BE SELECTED BEFORE REPOSITIONING THE REAR WHEELS FORWARD. DO NOT OPERATE THE TILT-IN-SPACE IF THE TRIGGER RELEASE LEVERS AND CABLES ARE NOT PROPERLY ADJUSTED TO ENSURE THAT THE TILT-IN-SPACE IS LOCKED IN PLACE WHEN ENGAGED. PINCH POINT MAY OCCUR WHEN RETURNING THE TILTED SEAT TO THE FULL UPRIGHT POSITION. MAKE SURE THE HANDS AND BODY OF THE OCCUPANT, ATTENDANTS AND BYSTANDERS ARE CLEAR OF ALL PINCH POINTS BEFORE RETURNING THE TILTED SEAT TO THE FULL UPRIGHT POSITION. DO NOT TRAVERSE, CLIMB OR GO DOWN RAMPS OR SLOPES GREATER THAN 9°. NEVER LEAVE THE OCCUPIED WHEELCHAIR UNATTENDED AT ANY TIME, ESPECIALLY ON AN INCLINE. DO NOT ATTEMPT TO REACH OBJECTS IF YOU HAVE TO MOVE FORWARD IN THE SEAT. DO NOT ATTEMPT TO REACH OBJECTS IF YOU HAVE TO PICK THEM UP FROM THE FLOOR BY REACHING DOWN BETWEEN YOUR KNEES. UNLESS OTHERWISE NOTED, ALL SERVICE AND ADJUSTMENTS SHOULD BE PERFORMED WHILE THE WHEELCHAIR IS UNOCCUPIED. IF THE WHEELCHAIR IS EXPOSED TO EXTREME TEMPERATURE (ABOVE 100°F OR BELOW 32°F), HIGH HUMIDITY AND/OR BECOMES WET, PRIOR TO USE, ENSURE HANDGRIPS DO NOT TWIST ON THE WHEELCHAIR HANDLE - OTHERWISE DAMAGE OR INJURY MAY OCCUR. THE NECESSARY BACK ANGLE (90°, 100°, 110° OR 120°) MUST BE SELECTED BEFORE REPOSITIONING THE REAR WHEELS FORWARD. DO NOT OPERATE THE TILT-IN-SPACE IF THE TRIGGER RELEASE LEVERS AND CABLES ARE NOT PROPERLY ADJUSTED TO ENSURE THAT THE TILT-IN-SPACE IS LOCKED IN PLACE WHEN ENGAGED. DO NOT TRAVERSE, CLIMB OR GO DOWN RAMPS OR SLOPES GREATER THAN 9°. NEVER LEAVE THE OCCUPIED WHEELCHAIR UNATTENDED AT ANY TIME, ESPECIALLY ON AN INCLINE. DO NOT ATTEMPT TO REACH OBJECTS IF YOU HAVE TO MOVE FORWARD IN THE SEAT. DO NOT ATTEMPT TO REACH OBJECTS IF YOU HAVE TO PICK THEM UP FROM THE FLOOR BY REACHING DOWN BETWEEN YOUR KNEES. PAGE 18: DO NOT SHIFT YOUR WEIGHT OR SITTING POSITION TOWARD THE DIRECTION YOU ARE REACHING AS WHEELCHAIR MAY TIP OVER. DO NOT ATTEMPT TO STOP A MOVING WHEELCHAIR WITH WHEEL LOCKS. WHEEL LOCKS ARE NOT BRAKES. DO NOT TIP THE WHEELCHAIR ONTO THE REAR WHEELS WITHOUT ASSISTANCE. DO NOT USE AN ESCALATOR TO MOVE A WHEELCHAIR BETWEEN FLOORS. SERIOUS BODILY INJURY MAY OCCUR. BEFORE ATTEMPTING TO TRANSFER IN OR OUT OF THE WHEELCHAIR, EVERY PRECAUTION SHOULD BE TAKEN TO REDUCE THE GAP DISTANCE. TURN BOTH CASTERS PARALLEL TO THE OBJECT YOU ARE TRANSFERRING ONTO. WHEN TRANSFERRING TO AND FROM THE WHEELCHAIR, ALWAYS ENGAGE BOTH WHEEL LOCKS. DO NOT USE WHEELCHAIR UNLESS IT HAS THE PROPER TIRE PRESSURE (P.S.I.). DO NOT OVERINFLATE THE TIRES. FAILURE TO FOLLOW THESE SUGGESTIONS MAY CAUSE THE TIRE TO EXPLODE AND CAUSE BODILY HARM. RECOMMENDED TIRE PRESSURE IS LISTED ON THE SIDE WALL OF THE TIRE. DO NOT ATTEMPT TO LIFT A WHEELCHAIR BY LIFTING ON ANY REMOVABLE (DETACHABLE) PARTS. LIFTING BY MEANS OF ANY REMOVABLE (DETACHABLE) PARTS OF A WHEELCHAIR MAY RESULT IN INJURY TO THE USER OR DAMAGE TO THE WHEELCHAIR. DO NOT STAND ON THE FRAME OF THE WHEELCHAIR. ANTI-TIPPERS MUST BE ATTACHED AT ALL TIMES. DO NOT USE THE FOOTPLATES AS A PLATFORM. WHEN GETTING IN OR OUT OF THE WHEELCHAIR, MAKE SURE THAT THE FOOTPLATES ARE IN THE UPWARD POSITION. ALWAYS USE THE HANDRIMS FOR SELF-PROPULSION. INASMUCH AS THE HANDRIMS ARE AN OPTION ON THIS WHEELCHAIR (YOU MAY ORDER WITH OR WITHOUT THE HANDRIMS), INVACARE STRONGLY RECOMMENDS ORDERING THE HANDRIMS AS AN ADDITIONAL SAFEGUARD FOR THE WHEELCHAIR USER. IF WHEELCHAIR IS EXPOSED TO EXTREME TEMPERATURE (ABOVE 100°F OR BELOW 32°F), HIGH HUMIDITY AND/OR BECOMES WET, PRIOR TO USE, ENSURE HANDGRIPS DO NOT TWIST ON (PRODUCT NAME HERE) HANDLE - OTHERWISE DAMAGE OR INJURY MAY OCCUR. ALWAYS USE ANTI-TIPPERS. WHEN OUTDOORS ON WET, SOFT GROUND OR ON GRAVEL SURFACES, ANTITIPPERS MAY NOT PROVIDE THE SAME LEVEL OF PROTECTION AGAINST TIP OVER. EXTRA CAUTION MUST BE OBSERVED WHEN TRAVERSING SUCH SURFACES. DO NOT USE THE SPREADER BAR FOR LIFTING OR TRANSPORTING THE WHEELCHAIR. DO NOT USE THE SPREADER BAR AS A WEIGHT BEARING SUPPORT. MAKE SURE DETENT BALLS OF THE QUICK-RELEASE PIN ARE FULLY RELEASED BEFORE OPERATING THE WHEELCHAIR. THE DETENT BALLS MUST BE PROTRUDING PAST THE TOP OF THE SEAT PLATE ASSEMBLY FOR A POSITIVE LOCK. KEEP DETENT BALLS CLEAN

    Description of Event or Problem · 1

    THE CONSUMER'S FATHER SENT A LETTER ALLEGING THE FRAME HAS BROKEN MULTIPLE TIMES ON THE CONSUMER'S WHEELCHAIR. THERE ARE DRAWINGS OF WHERE THE BREAK ALLEGEDLY OCCURRED FROM THE CONSUMER'S FATHER. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SOLARA 2G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other