BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2221373 · Received August 24, 2011

    Report

    Report Number
    1525712-2011-00459
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 23, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THIS DEVICE. INVACARE PROVIDES A USER MANUAL FOR MODEL TDXSP-CG PART NO 1143190 REV I - 06/10. IT IS UNKNOWN IF THE CONSUMER OF THE DEVICE HAS READ AND FULLY UNDERSTANDS THE USER MANUAL. THE FOLLOWING WARNINGS ADN GUIDELINES MAY HAVE PREVENTED THE CONSUMER FROM TIPPING OVER AND FALLING ONTO HIS SIDE BREAKING THE CHAIR. 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. PAGE 11 ACCESSORIES WARNINGS" INVACARE PRODUCTS ARE SPECIFICALLY DESIGNED AND MANUFACTURED FOR USE IN CONJUNCTION WITH INVACARE ACCESSORIES. ACCESSORIES DESIGNED BY OTHER MANUFACTURERS HAVE NOT BEEN TESTED BY INVACARE AND ARE NOT RECOMMENDED FOR USE WITH INVACARE PRODUCTS. DO NOT CONNECT ANY MEDICAL DEVICES SUCH AS VENTILATORS, LIFE SUPPORT MACHINES, ETC., DIRECTLY TO THE BATTERIES USED TO POWER THE WHEELCHAIR. THIS COULD CAUSE UNEXPECTED FAILURE OF THE DEVICE AND THE WHEELCHAIR. PAGE 11 NOTICE: CHECK ALL PARTS FOR SHIPPING DAMAGE AND TEST BEFORE USING. IN CASE OF DAMAGE DO NOT USE. CONTACT INVACARE/CARRIER FOR FURTHER INSTRUCTION. AS A MANUFACTURER OF WHEELCHAIRS, INVACARE ENDEAVORS TO SUPPLY A WIDE VARIETY OF WHEELCHAIRS TO MEET MANY NEEDS OF THE END USER. HOWEVER, FINAL SELECTION OF THE TYPE OF WHEELCHAIR TO BE USED BY AN INDIVIDUAL RESTS SOLELY WITH THE USER AND HIS/HER HEALTHCARE PROFESSIONAL CAPABLE OF MAKING SUCH A SELECTION. INVACARE HIGHLY RECOMMENDS WORKING WITH A CERTIFIED REHAB TECHNOLOGY SUPPLIER AND/OR A MEMBER OF NRRTS OR RESNA. PAGE 12 WARNING [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 PAGE 13 WARNING [TERRAIN, BRAKES, RESTRAINTS]: DO NOT OPERATE ON ROADS, STREETS OR HIGHWAYS. WHEELCHAIR TIE-DOWN RESTRAINTS AND SEAT RESTRAINTS (TRRO OR TRBKTS) ONLY USE THE TRANSPORT BRACKETS INCLUDED WITH TRRO OR TRBKTS FOR THE PURPOSES DESCRIBED IN THIS MANUAL. TRRO (TRANSPORT READY OPTION) - TRRO INCLUDES FOUR FACTORY-INSTALLED TRANSPORT BRACKETS AND A WHEELCHAIR ANCHORED PELVIC BELT. TRRO HAS BEEN CRASH-TESTED IN ACCORDANCE WITH ANSI/RESNA WC VOL 1 SECTION 19 FRONTAL IMPACT TEST REQUIREMENTS FOR WHEELCHAIRS WITH A 130 LB CRASH TEST DUMMY, WHICH CORRESPONDS TO A PERSON WITH A WEIGHT OF 125 TO 165 LBS. FOR JUNIOR SEAT SIZES OR A 168 LB CRASH DUMMY, WHICH CORRESPONDS TO A PERSON WITH A WEIGHT OF 165 TO 300 LBS. FOR ADULT SEAT SIZES. AS OF THIS DATE, THE DEPARTMENT OF TRANSPORTATION HAS NOT APPROVED ANY TIE-DOWN SYSTEMS FOR TRANSPORTATION OF A USER WHILE IN A WHEELCHAIR, IN A MOVING VEHICLE OF ANY TYPE. IT IS INVACARE'S POSITION THAT USERS OF WHEELCHAIRS SHOULD BE TRANSFERRED INTO APPROPRIATE SEATING IN VEHICLES FOR TRANSPORTATION AND USE BE MADE OF THE RESTRAINTS MADE AVAILABLE BY THE AUTO INDUSTRY. INVACARE CANNOT AND DOES NOT RECOMMEND ANY WHEELCHAIR TRANSPORTATION SYSTEMS. BATTERY SUPPORT BRACKETS MUST BE INSTALLED AT ALL TIMES. OTHERWISE, THE WHEELCHAIR WILL NOT BE WC/19 COMPLIANT. REFER TO TRANSPORT READY OPTION (TRRO) ON PAGE 64. REFER TO TRANSPORT READY OPTION (TRRO) ON PAGE 64 FOR MORE INFORMATION ABOUT TRANSPORTING THE WHEELCHAIR. PAGE 14 WARNING [STAIRS, ESCALATORS]: STAIRWAYS AND ESCALATORS DO NOT ATTEMPT TO MOVE AN OCCUPIED POWER WHEELCHAIR BETWEEN FLOORS USING A STAIRWAY. USE AN ELEVATOR TO MOVE AN OCCUPIED POWER WHEELCHAIR BETWEEN FLOORS. IF MOVING A POWER WHEELCHAIR BETWEEN FLOORS BY MEANS OF A STAIRWAY, THE OCCUPANT MUST BE REMOVED AND TRANSPORTED INDEPENDENTLY OF THE POWER WHEELCHAIR. EXTREME CAUTION IS ADVISED WHEN IT IS NECESSARY TO MOVE AN UNOCCUPIED POWER WHEELCHAIR UP OR DOWN THE STAIRS. INVACARE RECOMMENDS USING TWO ASSISTANTS AND MAKING THOROUGH PREPARATIONS. MAKE SURE TO USE ONLY SECURE, NON-DETACHABLE PARTS FOR HAND-HOLD SUPPORTS. DO NOT USE AN ESCALATOR TO MOVE A WHEELCHAIR BETWEEN FLOORS. SERIOUS BODILY INJURY MAY OCCUR. DO NOT ATTEMPT TO LIFT THE WHEELCHAIR BY 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. THE WEIGHT OF THE WHEELCHAIR WITHOUT THE USER AND WITHOUT BATTERIES IS BETWEEN 166 AND 322 LBS. USE PROPER LIFTING TECHNIQUES (LIFT WITH YOUR LEGS) TO AVOID INJURY. REPAIR OR SERVICE INFORMATION: PAGE 15 WARNING [SERVICE]: 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. PAGE 16 WARNING [SAFETY]: THE SEAT POSITIONING STRAP IS A POSITIONING BELT ONLY. IT IS NOT DESIGNED FOR USE AS A SAFETY DEVICE WITHSTANDING HIGH STRESS LOADS SUCH AS AUTO OR AIRCRAFT SAFETY BELTS. IF SIGNS OF WEAR APPEAR, BELT MUST BE REPLACED IMMEDIATELY. DO NOT LEAVE THE POWER BUTTON ON WHEN ENTERING OR EXITING YOUR WHEELCHAIR. DO NOT GO UP OR DOWN RAMPS OR TRAVERSE SLOPES GREATER THAN 9 DEGREES. NEVER LEAVE AN UNOCCUPIED WHEELCHAIR UNATTENDED ON AN INCLINE. DO NOT ATTEMPT TO MOVE UP OR DOWN AN INCLINE WITH WATER, ICE OR OIL FILM. DO NOT ATTEMPT TO MOVE UP OR DOWN AN INCLINE WITH WATER, ICE OR OIL FILM. DO DETERMINE AND ESTABLISH YOUR PARTICULAR SAFETY LIMITS BY PRACTICING BENDING, REACHING AND TRANSFERRING ACTIVITIES IN THE PRESENCE OF A QUALIFIED HEALTHCARE PROFESSIONAL BEFORE ATTEMPTING ACTIVE USE OF THE WHEELCHAIR. PAGE 17 WARNING : [REACHING - BODY POSITION - WHEEL LOCKS ARE NOT BREAKS. TIRE INFLATION.] DO NOT ATTEMPT TO REACH OBJECTS IF YOU HAVE TO MOVE FORWARD IN YOUR SEAT. ALWAYS SHIFT YOUR WEIGHT IN THE DIRECTION YOU ARE TURNING. DO NOT SHIFT YOUR WEIGHT IN THE OPPOSITE DIRECTION OF THE TURN. SHIFTING YOUR WEIGHT IN THE OPPOSITE DIRECTION OF THE TURN MAY CAUSE THE INSIDE DRIVE WHEEL TO LOSE TRACTION AND THE WHEELCHAIR TO TIP OVER. DO NOT SHIFT YOUR WEIGHT OR SITTING POSITION TOWARD THE DIRECTION YOU ARE REACHING AS THE WHEELCHAIR AND/OR SEATING SYSTEM (IF ANY) MAY TIP OVER. ALWAYS KEEP HANDS AND FINGERS CLEAR OF MOVING PARTS TO AVOID INJURY. DO NOT USE WITH A BROKEN OR MISSING JOYSTICK KNOB. DO NOT USE IF JOYSTICK DOES NOT SPRING BACK TO THE NEUTRAL POSITION OR BECOMES STICKY OR SLUGGISH. DO NOT USE IF JOYSTICK BOOT IS TORN OR DAMAGED. ALWAYS CHECK FOAM GRIPS FOR LOOSENESS BEFORE USING THE WHEELCHAIR. IF LOOSE, CONTACT A QUALIFIED TECHNICIAN FOR INSTRUCTIONS. DO NOT ATTEMPT TO STOP A MOVING WHEELCHAIR WITH THE WHEEL LOCKS. WHEEL LOCKS ARE NOT BRAKES. DO NOT ENGAGE OR DISENGAGE THE MOTOR LOCKS UNTIL THE POWER IS IN THE OFF POSITION. DO NOT USE YOUR WHEELCHAIR UNLESS IT HAS THE PROPER TIRE PRESSURE (P.S.I.). DO NOT OVERINFLATE THE TIRES. FAILURE TO FOLLOW THESE RECOMMENDATIONS MAY CAUSE THE TIRE TO EXPLODE AND CAUSE BODILY HARM. THE RECOMMENDED TIRE PRESSURE IS LISTED ON THE SIDE WALL OF THE TIRE. PAGE 18 WARNING [JOYSTICK - WHEEL LOCKS - TIRES]: DO NOT USE WITH A BROKEN OR MISSING JOYSTICK KNOB. DO NOT USE IF JOYSTICK DOES NOT SPRING BACK TO THE NEUTRAL POSITION OR BECOMES STICKY OR SLUGGISH. DO NOT USE IF JOYSTICK BOOT IS TORN OR DAMAGED. ALWAYS CHECK FOAM GRIPS FOR LOOSENESS BEFORE USING THE WHEELCHAIR. IF LOOSE, CONTACT A QUALIFIED TECHNICIAN FOR INSTRUCTIONS. DO NOT ATTEMPT TO STOP A MOVING WHEELCHAIR WITH THE WHEEL LOCKS. WHEEL LOCKS ARE NOT BRAKES. DO NOT ENGAGE OR DISENGAGE THE MOTOR LOCKS UNTIL THE POWER IS IN THE OFF POSITION. DO NOT USE YOUR WHEELCHAIR UNLESS IT HAS THE PROPER TIRE PRESSURE (P.S.I.). DO NOT OVERINFLATE THE TIRES. FAILURE TO FOLLOW THESE RECOMMENDATIONS MAY CAUSE THE TIRE TO EXPLODE AND CAUSE BODILY HARM. THE RECOMMENDED TIRE PRESSURE IS LISTED ON THE SIDE WALL OF THE TIRE. PAGE 19 WARNING [STABILITY AND BALANCE]: ALWAYS WEAR YOUR SEAT POSITIONING STRAP. THE SEAT POSITIONING STRAP IS A POSITIONING BELT ONLY. IT IS NOT DESIGNED FOR USE AS A SAFETY DEVICE WITHSTANDING HIGH STRESS LOADS SUCH AS AUTO OR AIRCRAFT SAFETY BELTS. IF SIGNS OF WEAR APPEAR, BELT MUST BE REPLACED IMMEDIATELY. THE DRIVE BEHAVIOR INITIALLY EXPERIENCED BY THE USER MAY BE DIFFERENT FROM OTHER WHEELCHAIRS PREVIOUSLY USED. THIS POWER WHEELCHAIR HAS INVACARE'S SURESTEP TECHNOLOGY, A FEATURE THAT PROVIDES THE WHEELCHAIR WITH OPTIMUM TRACTION AND STABILITY WHEN DRIVING FORWARD OVER TRANSITIONS AND THRESHOLDS OF UP TO 3-INCHES. THE FOLLOWING WARNINGS APPLY SPECIFICALLY TO THE SURESTEP FEATURE: DO NOT USE ON INCLINES GREATER THAN 9 DEGREES. DO NOT USE ON INCLINES WITH WET, SLIPPERY, ICY OR OILY SURFACES. THIS MAY INCLUDE CERTAIN PAINTED OR OTHERWISE TREATED WOOD SURFACES. DO NOT TRAVERSE DOWN RAMPS AT HIGH SPEED. DOING SO WILL REDUCE TRACTION AND INCREASE STOPPING DISTANCE. ALWAYS TRAVERSE DOWN RAMPS AT A REDUCED, CONSTANT SPEED TO MAINTAIN STABILITY AND TO AVOID HARD BRAKING OR SUDDEN STOPS. THE END USER'S WEIGHT CAN MATERIALLY AFFECT TRACTION ON SLOPED SURFACES. GREAT CARE SHOULD BE TAKEN WHEN TRAVERSING SUCH SLOPES. ALWAYS REDUCE SPEED WHEN TRAVELING UP OR DOWN AN INCLINE OR OVER OBSTACLES AND ROUGH TERRAIN. TRAVELING UNDER THESE CONDITIONS MAY SHIFT THE USERS WEIGHT FORWARD RESULTING IN REDUCED STABILITY. PAGE 20 WARNING [SAFETY]: EXERCISE CAUTION AND AVOID SUDDEN STOPS WHEN TRAVELING UP OR DOWN AN INCLINE OR OVER OBSTACLES AND ROUGH TERRAIN. IF STOPPING BECOMES NECESSARY UNDER THESE DRIVING CONDITIONS, RELEASE THE JOYSTICK AND ALLOW THE WHEELCHAIR TO COME TO A FULL STOP. THEN PROCEED AT A SLOWER SPEED. DO NOT TRAVERSE DOWN RAMPS AT HIGH SPEED. DOING SO WILL REDUCE TRACTION AND INCREASE STOPPING DISTANCE. DO NOT LEAVE ELEVATING LEG RESTS IN THE FULLY EXTENDED POSITION WHEN PROCEEDING DOWN RAMPS OR SLOPES. TO DETERMINE AND ESTABLISH YOUR PARTICULAR SAFETY LIMITS, PRACTICE USE OF THIS PRODUCT ON VARIOUS SLOPING SURFACES IN THE PRESENCE OF A QUALIFIED HEALTHCARE PROVIDER BEFORE ATTEMPTING ACTIVE USE OF THIS WHEELCHAIR. OTHER GENERAL WARNINGS LISTED WITHIN THIS DOCUMENT ALSO APPLY. BE AWARE THAT CARRYING HEAVY OBJECTS ON YOUR LAP WHILE OCCUPYING THE WHEELCHAIR MAY ADVERSELY AFFECT THE STABILITY OF THE WHEELCHAIR, RESULTING IN SERIOUS BODILY INJURY TO THE USER, DAMAGE TO THE WHEELCHAIR AND SURROUNDING PROPERTY. THIS WHEELCHAIR HAS BEEN DESIGNED TO ACCOMMODATE ONE INDIVIDUAL. IF MORE THAN ONE INDIVIDUAL OCCUPIES THE WHEELCHAIR THIS MAY ADVERSELY AFFECT THE STABILITY OF THE WHEELCHAIR, RESULTING IN SERIOUS BODILY INJURY TO THE USER AND PASSENGER AND DAMAGE TO THE WHEELCHAIR AND SURROUNDING PROPERTY. MANY ACTIVITIES REQUIRE THE WHEELCHAIR USER TO REACH, BEND AND TRANSFER IN AND OUT OF THE WHEELCHAIR. THESE MOVEMENTS WILL CAUSE A CHANGE TO THE NORMAL BALANCE, CENTER OF GRAVITY, AND WEIGHT DISTRIBUTION OF THE WHEELCHAIR. TO DETERMINE AND ESTABLISH YOUR PARTICULAR SAFETY LIMITS, PRACTICE BENDING, REACHING AND TRANSFERRING ACTIVITIES IN SEVERAL COMBINATIONS IN THE PRESENCE OF A QUALIFIED HEALTHCARE PROFESSIONAL BEFORE ATTEMPTING ACTIVE USE OF THE WHEELCHAIR. DO NOT STAND ON THE FRAME OF THE WHEELCHAIR. PAGE 21 WARNING [CURBS]: DO NOT ATTEMPT TO DRIVE OVER CURBS OR OBSTACLES GREATER THAN 3 INCHES. DOING SO MAY CAUSE YOUR WHEELCHAIR TO TURN OVER AND CAUSE BODILY HARM OR DAMAGE TO THE WHEELCHAIR. ALWAYS STOP BEFORE CLIMBING AN OBSTACLE. APPROACH SLOWLY UNTIL FRONT ANTI-TIP WHEELS ARE APPROXIMATELY 18 INCHES AWAY FROM THE OBSTACLE. SLOWLY APPLY POWER TO MOVE FORWARD, OVER THE OBSTACLE. PAGE 21 CAUTION [RAMPS, SLIPPERY]: BE AWARE OF THE CONDITION OF THE RAMP. TRACTION WILL BE DIMINISHED/NONEXISTENT ON A SLIPPERY SURFACE. PROCEED WITH CAUTION. PAGE 23 WARNING [REACHING, BENDING - LEANING FORWARD] DO NOT ATTEMPT TO REACH OBJECTS IF YOU HAVE TO MOVE FORWARD IN THE SEAT OR PICK THEM UP FROM THE FLOOR BY REACHING DOWN BETWEEN YOUR KNEES. PROPER POSITIONING IS ESSENTIAL FOR YOUR SAFETY. IMPROPER POSITIONING WHILE LEANING OR BENDING COULD CAUSE THE WHEELCHAIR TO TIP FORWARD ONTO ANTI-TIPPERS. PAGE 24 WARNING [BENDING - LEANING BACKWARD]: DO NOT LEAN OVER THE TOP OF THE BACK UPHOLSTERY. THIS WILL CHANGE YOUR CENTER OF GRAVITY AND MAY CAUSE YOU TO TIP OVER. PROPER POSITIONING IS ESSENTIAL FOR YOUR SAFETY. WHEN REACHING, LEANING, BENDING OR BENDING BACKWARD, IT IS IMPORTANT TO USE THE CASTERS AS A TOOL TO MAINTAIN STABILITY AND BALANCE. PAGE 29 WARNING [WEIGHT LIMITATIONS]: REFER TO TECHNICAL DATA ON PAGE 36 TO DETERMINE THE WEIGHT LIMIT (TOTAL COMBINED WEIGHT OF USER AND ANY ATTACHMENTS) OF YOUR WHEELCHAIR MODEL. DO NOT EXCEED THE LIMIT - OTHERWISE, INJURY OR DAMAGE MAY RESULT. PAGE 31 WARNING [SAFETY]: DO NOT OPERATE HAND-HELD TRANSCEIVERS (TRANSMITTERS RECEIVERS), SUCH AS CITIZENS BAND (CB) RADIOS, OR TURN ON PERSONAL COMMUNICATION DEVICES, SUCH AS CELLULAR PHONES, WHILE THE POWERED WHEELCHAIR IS TURNED ON; BE AWARE OF NEARBY TRANSMITTERS, SUCH AS RADIO OR TV STATIONS, AND TRY TO AVOID COMING CLOSE TO THEM; IF UNINTENDED MOVEMENT OR BRAKE RELEASE OCCURS, TURN THE POWERED WHEELCHAIR OFF AS SOON AS IT IS SAFE; BE AWARE THAT ADDING ACCESSORIES OR COMPONENTS, OR MODIFYING THE POWERED WHEELCHAIR, MAY MAKE IT MORE SUSCEPTIBLE TO EMI (NOTE: THERE IS NO EASY WAY TO EVALUATE THEIR EFFECT ON THE OVERALL IMMUNITY OF THE POWERED WHEELCHAIR); AND REPORT ALL INCIDENTS OF UNINTENDED MOVEMENT OR BRAKE RELEASE TO THE POWERED WHEELCHAIR MANUFACTURER, AND NOTE WHETHER THERE IS A SOURCE OF EMI NEARBY. IMPORTANT INFORMATION: 20 VOLTS PER METER (V/M) IS A GENERALLY ACHIEVABLE AND USEFUL IMMUNITY LEVEL AGAINST EMI (AS OF MAY 1994) (THE HIGHER THE LEVEL, THE GREATER THE PROTECTION); THIS DEVICE HAS BEEN TESTED TO A RADIATED IMMUNITY LEVEL OF 20 VOLTS PER METER. THE IMMUNITY LEVEL OF THE PRODUCT IS UNKNOWN. MODIFICATION OF ANY KIND TO THE ELECTRONICS OF THIS SCOOTER AS MANUFACTURED BY INVACARE MAY ADVERSELY AFFECT THE EMI IMMUNITY LEVELS. 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. PAGE 59 WARNING [ENGAGING/DISENGAGING MOTOR LOCKS]: DO NOT ENGAGE OR DISENGAGE MOTOR LOCKS UNTIL THE POWER IS IN THE OFF POSITION. PAGE 61 WARNING [ENGAGING/DISENGAGING WHEEL LOCKS]: DO NOT USE THE WHEEL LOCKS WHEN THE WHEELCHAIR POWER IS ON AND THE CLUTCHES ARE ENGAGED - OTHERWISE DAMAGE TO THE WHEELCHAIR MAY RESULT. PAGE 72 WARNING [POSITIONING BELTS]: THE ANGLE OF THE PELVIC BELT SHOULD BE WITHIN THE PREFERRED ZONE OF 45 TO 75 DEGREES TO THE HORIZONTAL OR WITHIN THE OPTIONAL ZONE OF 30 TO 45 DEGREES TO THE HORIZONTAL. STEEPER SIDE-VIEW PELVIC BELT ANGLES ARE ESPECIALLY IMPORTANT IF THE PELVIC BELT IS INTENDED TO BE USED FOR POSTURAL SUPPORT IN ADDITION TO OCCUPANT RESTRAINT IN A FRONTAL CRASH. STEEPER ANGLES WILL REDUCE THE TENDENCY FOR A VERTICAL GAP TO DEVELOP BETWEEN THE USER AND THE BELT DUE TO COMPLIANCE OF SEAT CUSHIONS AND BELT MOVEMENT, THEREBY REDUCING THE TENDENCY FOR THE USER TO SLIP UNDER THE BELT AND FOR THE BELT TO RIDE UP ON THE SOFT ABDOMEN DURING NORMAL USE STEEPER BELT ANGLES ALSO REDUCE THE TENDENCY FOR UPPER-TORSO BELTS TO PULL THE PELVIC BELT ONTO THE ABDOMEN DURING FRONTAL IMPACT LOADING. PAGE 75 CAUTION [WHEEL CONDITION]: AS WITH ANY VEHICLE, THE WHEELS AND TIRES SHOULD BE CHECKED PERIODICALLY FOR CRACKS AND WEAR, AND SHOULD BE REPLACED. PAGE 77 WARNING [SERVICE]: AFTER ANY ADJUSTMENTS, REPAIR OR SERVICE AND BEFORE USE, MAKE SURE THAT ALL ATTACHING HARDWARE IS TIGHTENED SECURELY - OTHERWISE INJURY OR DAMAGE MAY RESULT. PAGE 77 CAUTION [SERVICE]: AS WITH ANY VEHICLE, THE WHEELS AND TIRES SHOULD BE CHECKED PERIODICALLY FOR CRACKS AND WEAR, AND SHOULD BE REPLACED. PAGE 97 WARNING [CONNECTING THE JOY STICK]: THE JOYSTICK CONNECTOR AND CONTROLLER CONNECTOR FIT TOGETHER IN ONE WAY ONLY. DO NOT FORCE THEM TOGETHER.

    Description of Event or Problem · 1

    THE NURSE AT A REHAB HOSPITAL STATES THE CONSUMER WAS DRIVING HIS POWER CHAIR OUTSIDE AND IT ALLEGEDLY TIPPED OVER, CAUSING THE CONSUMER TO FALL ON HIS SIDE. THE CONSUMER WAS NOT INJURED, BUT THE SIDE OF THE CHAIR ALLEGEDLY BROKE.

    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