BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2220921 · Received August 23, 2011

    Report

    Report Number
    9616091-2011-00002
    Date Received
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS WHEEL CHAIR. THE DEVICE IS 14 MONTHS OLD. IT IS UNKNOWN IF THE CONSUMER HAS READ AND FULLY UNDERSTANDS THE USER MANUAL FOR THE TREX2 PART NO 1110546. THE CONSUMER'S MAINTENANCE AND USAGE OF THE WHEEL CHAIR ARE UNKNOWN. THE WEIGHT OF THE CONSUMER IS UNKNOWN. THE LOADING OF THE DEVICE IS UNKNOWN. THE FOLLOWING WARNINGS ARE PROVIDED TO THE CONSUMER TO PREVENT BROKEN PARTS AND PEELING CHROME ON HAND RIMS. 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. 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. 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. PAGE 13 _ WARNING: 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. INVACARE RECOMMENDS THAT A NON-FOLDING DEVICE BE INSTALLED TO KEEP THE WHEELCHAIR FROM BEING FOLDED WHEN LEFT UNOCCUPIED IN A PUBLIC PLACE. 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. DO NOT OVERTIGHTEN HARDWARE ATTACHING TO THE FRAME. THIS COULD CAUSE DAMAGE TO THE FRAME TUBING. PAGE 14 _ WARNING: 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. PAGE 14 _ WARNING: DO NOT ATTEMPT TO LIFT THE WHEELCHAIR BY ANY REMOVABLE (DETACHABLE) PARTS. LIFTING BY MEANS OF ANY REMOVABLE (DETACHABLE) PARTS OF THE WHEELCHAIR MAY RESULT IN INJURY TO THE USER OR DAMAGE TO THE WHEELCHAIR. PAGE 15_ 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. WEIGHT LIMITATION: THE TRACER EX2 HAS A WEIGHT LIMITATION OF 250 POUNDS (114 KG).

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE SIDE PANELS ARE WEAK AND HAVE BROKEN TWICE. THE ARMRESTS ARE ALLEGEDLY TEARING AND CRACKING OPEN, AND THE HANDRIMS ARE ALLEGEDLY PEELING AND SHREDDING. NO INJURY IS ALLEGED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX28RF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other