BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2253205 · Received September 19, 2011

    Report

    Report Number
    9616091-2011-00008
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 20, 2011
    Report Date
    September 17, 2011
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THE DEVICE. THE MODEL TRSX MANUAL CHAIR DID NOT HAVE A SERIAL NUMBER PROVIDED. THEREFORE, THE AGE OF THE DEVICE CAN NOT BE DETERMINED. HENCE, THE CORRECT REVISION USERS MANUAL IS UNKNOWN. FOR DOCUMENTATION SAKE THE LATEST REVISION WILL BE USED FOR DOCUMENTATION IN THIS SUBMISSION. OWNERS MANUAL - INVACARE TRACER SX5 WHEELCHAIR PART NO. (B)(4). IT IS UNKNOWN IF THE CONSUMER FULLY READ AND UNDERSTANDS THE USERS MANUAL. THE FOLLOWING WARNING IS PROVIDED ON PAGE 5: "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. A QUALIFIED TECHNICIAN MUST PERFORM THE INITIAL SET UP OF THIS WHEELCHAIR. ALSO, A QUALIFIED TECHNICIAN MUST PERFORM ALL PROCEDURES SPECIFICALLY INDICATED IN THE MANUAL." IT IS UNKNOWN IF THE CONSUMER HAS NON-INVACARE ACCESSORIES ON THE DEVICE. THE FOLLOWING WARNING IS PROVIDE ON PAGE 5 TO PREVENT THIS: "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." IT IS UNKNOWN IF THE CONSUMER ADHERES TO THE GENERAL WARNING ON PAGE 10. BY FOLLOWING THESE WARNINGS, IT HAVE PREVENTED THE SPOKE FROM BREAKING LEADING TO THE CONSUMER FALL. THE GENERAL WARNINGS STATE: "GENERAL WARNINGS -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. AVOID STORING OR USING THE WHEELCHAIR NEAR OPEN FLAME OR COMBUSTIBLE PRODUCTS. SERIOUS INJURY OR DAMAGE TO PROPERTY MAY RESULT." "DO NOT STAND ON THE FRAME OF THE WHEELCHAIR." "DO NOT USE THE FOOTPLATE 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." "DO NOT OPERATE ON ROADS, STREETS OR HIGHWAYS." "DO NOT ALLOW CHILDREN TO PLAY ON OR OPERATE THE WHEELCHAIR." "DO NOT OPERATE ON SOFT SURFACES SUCH AS SAND, GRASS, OR GRAVEL." IT IS UNKNOWN OF THE HAND GRIPS WERE A FACTOR IN THE INCIDENT. ON PAGE 11 THE FOLLOWING WARNINGS ARE PROVIDED - "HAND GRIPS WARNINGS - ALWAYS CHECK HAND GRIPS FOR LOOSENESS BEFORE USING THE WHEELCHAIR. IF LOOSE AND/OR WORN, REPLACE IMMEDIATELY. WHEN CLEANING REAR CANE OR HAND GRIP AREAS USE ONLY A CLEAN TOWEL LIGHTLY DAMPENED WITH COOL WATER. VERIFY THAT GRIPS ARE DRY PRIOR TO USE. USE OF SOAP OR AMMONIA BASED CLEANING SOLUTIONS WILL RESULT IN THE HAND GRIPS SLIDING OFF THE CANE ASSEMBLY. FAILURE TO OBSERVE THIS WARNING MAY RESULT IN INJURY TO THE USER OR BYSTANDERS. 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 THAT THE HANDGRIPS DO NOT TWIST ON THE HANDLE. OTHERWISE, DAMAGE OR INJURY MAY OCCUR." IT IS UNKNOWN WHAT THE TERRAIN WAS AT THE TIME OF THE INCIDENT. THE FOLLOWING WARNINGS ARE PROVIDED ON PAGE 12 -"WARNING -" "DO NOT TRAVERSE, CLIMB OR GO DOWN RAMPS OR SLOPES GREATER THAN 9°." "DO NOT ATTEMPT TO MOVE UP OR DOWN AN INCLINE WITH A WATER, ICE OR OIL FILM." "DO NOT ATTEMPT TO RIDE OVER CURBS OR OBSTACLES. DOING SO MAY CAUSE YOUR WHEELCHAIR TO TIP OVER AND CAUSE BODILY HARM TO YOU OR DAMAGE TO THE WHEELCHAIR." "NEVER LEAVE AN UNOCCUPIED WHEELCHAIR ON AN INCLINE." "DO NOT ATTEMPT TO STOP THE WHEELCHAIR WHILE ON A SLOPED SURFACE." THE MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN OF THE CONSUMER IS UNKNOWN. IT IS UNKNOWN IF THESE MAY HAVE CONTRIBUTED TO THE INCIDENT. ON PAGE 13 THE FOLLOWING WARNING IS PROVIDED: "WARNING - THE SEAT DEPTH, SIZE/POSITION OF THE FRONT CASTERS, SIZE/POSITION OF THE REAR WHEELS, USE OF ANTI-TIPPER MODEL, AS WELL AS THE USER CONDITION DIRECTLY RELATE TO THE STABILITY OF THE WHEELCHAIR. ANY CHANGE TO ONE OR ANY COMBINATION OF THE SEVEN MAY CAUSE THE WHEELCHAIR TO DECREASE IN STABILITY. THESE ADJUSTMENTS MUST BE PERFORMED BY A QUALIFIED TECHNICIAN. THE VARIOUS SEAT-TO-FLOOR HEIGHTS REQUIRE SPECIFIC SETTINGS DEPENDING ON REAR WHEEL SIZE, REAR WHEEL POSITION, FRONT CASTER SIZE/POSITION AND DESIRED SEAT-TO-FLOOR ANGLE. THESE ADJUSTMENTS MUST BE PERFORMED BY A QUALIFIED TECHNICIAN." IT IS UNKNOWN IF THE CONSUMER WAS BEING TIPPED TO MANEUVER ON STAIRS OR A CURB. STAIRS AND CURBS HAVE BEEN KNOWN TO IMPACT THE SPOKES OF CASTERS. THE FOLLOW WARNING IS PROVIDED. PAGE 18 "WARNING - DO NOT TIP THE WHEELCHAIR WITHOUT ASSISTANCE. WHEN LOWERING THE FRONT CASTERS OF THE WHEELCHAIR, DO NOT LET THE WHEELCHAIR DROP THE LAST FEW INCHES TO THE GROUND. THIS COULD RESULT IN INJURY TO THE OCCUPANT AND/OR DAMAGE TO THE WHEELCHAIR."

    Description of Event or Problem · 1

    THE SPOKE OF THE CASTER WHEEL ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL TO THE GROUND. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 58 Other