BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2268196 · Received September 28, 2011

    Report

    Report Number
    9616091-2011-00011
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 5, 2011
    Report Date
    September 28, 2011
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. THIS MODEL TRSX5RC HAS SERIAL NUMBER (B)(4). THE AGE OF THE DEVICE IS APPROXIMATELY 10 MONTHS OLD. USER MANUAL PART NUMBER (B)(4)). IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER MANUAL. ON PAGE 7 THE FOLLOWING WARNING IS PROVIDED: "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. THE CONSUMER'S SON WAS PUSHING THE CONSUMER OVER A STEP AND WHEN THE REAR WHEELS CAME OFF ON THE STEP, THE CHAIR ALLEGEDLY COLLAPSED AND FOLDED UP. THE CONSUMER ALLEGEDLY FLIPPED FORWARD OFF THE CHAIR ONTO THE FLOOR. THE CONSUMER STATED THAT THEY FELL FORWARD AND OUT OF THE CHAIR. THE CAREGIVER STATES OTHERWISE. THEY SAID THAT THE CONSUMER FELL SIDEWAYS. THE CONSUMERS SON ALLEGES THE "SEAT PART ON EACH CORNER OF THE X PART SITS ON 4 BRACKETS IS NOT SITTING IN THE BRACKETS". THE CONSUMER SON WAS THE ONLY ASSISTANT MOVING THE CHAIR DOWN THE STEPS. IT IS UNKNOWN IF THE CONSUMERS SON READ THE NOTE TO WHEEL CHAIR ASSISTANTS ON PAGE 17. "A NOTE TO WHEELCHAIR ASSISTANTS. WHEN ASSISTANCE TO THE WHEELCHAIR USER IS REQUIRED, REMEMBER TO USE GOOD BODY MECHANICS. KEEP YOUR BACK STRAIGHT AND BEND YOUR KNEES WHENEVER TIPPING THE WHEELCHAIR OR TRAVERSING CURBS, OR OTHER IMPEDIMENTS. 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. IF THE WHEELCHAIR IS EXPOSED TO EXTREME TEMPERATURE (ABOVE 100 DEGREES F OR BELOW 32 DEGREES F), HIGH HUMIDITY AND/OR BECOMES WET, PRIOR TO USE, ENSURE HANDGRIPS "DO NOT TWIST ON THE WHEELCHAIRS - HANDLE - OTHERWISE DAMAGE OR INJURY MAY OCCUR. ALSO, BE AWARE OF DETACHABLE PARTS SUCH AS ARMRESTS OR LEG RESTS. THESE MUST NEVER BE USED TO MOVE THE WHEELCHAIR OR AS LIFTING SUPPORTS, AS THEY MAY BE INADVERTENTLY RELEASED, RESULTING IN POSSIBLE INJURY TO THE USER AND/OR ASSISTANT(S). WHEN LEARNING A NEW ASSISTANCE TECHNIQUE, HAVE AN EXPERIENCED ASSISTANT HELP YOU BEFORE ATTEMPTING IT ALONE." THE CONSUMERS SON TIPPED THE WHEELCHAIR. ON PAGE 19 THE FOLLOWING WARNING IS PROVIDED: "WARNING - DO NOT TIP THE WHEELCHAIR WITHOUT ASSISTANCE." IT IS UNKNOWN IF THE WHEEL CHAIR HAS STEP TUBES. THERE ARE TWO METHODS FOR TIPPING ON PAGE 19 AND 20. "METHOD 1 - WHEELCHAIR WITH STEP TUBES: PLACE FOOT ON THE STEP TUBE AND BEGIN TO TILT THE WHEELCHAIR TOWARD YOU. APPLY A CONTINUOUS DOWNWARD MOTION UNTIL THE BALANCE POINT IS ACHIEVED AND THE FRONT CASTERS CLEAR THE CURB. AT THIS POINT, THE ASSISTANT WILL FEEL A DIFFERENCE IN THE WEIGHT DISTRIBUTION. ROLL THE WHEELCHAIR FORWARD AND SLOWLY LOWER THE FRONT OF THE WHEELCHAIR IN ONE CONTINUOUS MOVEMENT ONTO THE SIDEWALK. PUSH THE WHEELCHAIR FORWARD UNTIL THE REAR WHEELS ROLL UP AND OVER THE CURB." "METHOD 2 - WHEELCHAIR WITHOUT STEP TUBES: THIS METHOD REQUIRES TWO ASSISTANTS. THE SECOND ASSISTANT SHOULD BE POSITIONED AT THE FRONT OF THE WHEELCHAIR LIFTING UPWARD ON A NON-REMOVABLE (NON-DETACHABLE) PART OF THE WHEELCHAIR FRAME WHEN LIFTING THE WHEELCHAIR AND STABILIZING THE WHEELCHAIR WHEN THE WHEELCHAIR IS BEING LOWERED TO THE GROUND. THE FIRST ASSISTANT SHOULD STAND ON THE SIDEWALK AND TURN THE WHEELCHAIR SO THAT THE REAR WHEELS ARE AGAINST THE CURB. TURN THE ANTI-TIPPERS SO THE ANTI-TIP WHEELS ARE POINTING UP. THE WHEELCHAIR SHOULD BE TILTED BACK TO THE BALANCE POINT AND, IN ONE CONTINUOUS UPWARD MOVEMENT, THE REAR WHEELS SHOULD BE PULLED UP AND OVER THE CURB. DO NOT RETURN THE FRONT CASTERS TO THE GROUND UNTIL THE WHEELCHAIR HAS BEEN PULLED BACKWARD FAR ENOUGH FOR THE FRONT CASTERS TO CLEAR THE EDGE OF THE CURB." THE TECHNIQUE USED BY THE CONSUMER SON IS UNKNOWN. ON PAGE 20 THE FOLLOWING WARNING IS PROVIDED; "WARNING - 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." IT IS UNKNOWN IF THE CONSUMERS SON ADHERED TO THE WARNING PROVIDED ON PAGE 21: "WARNING - ALWAYS WEAR YOUR SEAT POSITIONING STRAP. INASMUCH AS THE SEAT POSITIONING STRAP IS AN OPTION ON THIS WHEELCHAIR (YOU MAY ORDER WITH OR WITHOUT THE SEAT POSITIONING STRAP), INVACARE STRONGLY RECOMMENDS ORDERING THE SEAT POSITIONING STRAP AS AN ADDITIONAL SAFEGUARD FOR THE WHEELCHAIR USER. THE SEAT POSITIONING STRAP IS A POSITIONING STRAP 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, STRAP MUST BE REPLACED IMMEDIATELY. DO NOT ATTEMPT TO LIFT A WHEELCHAIR BY LIFTING ON 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. ALWAYS CHECK HAND GRIPS FOR LOOSENESS BEFORE USING THE WHEELCHAIR. IF LOOSE AND/OR WORN, REPLACE IMMEDIATELY. EXTREME CAUTION IS ADVISED WHEN IT IS NECESSARY TO MOVE AN OCCUPIED OR UNOCCUPIED WHEELCHAIR UP OR DOWN THE STAIRS. INVACARE RECOMMENDS THAT, IF POSSIBLE, THE USER BE REMOVED FROM THE WHEELCHAIR PRIOR TO MOVING. INVACARE RECOMMENDS USING TWO ASSISTANTS AND MAKING THOROUGH PREPARATIONS. MAKE SURE TO USE ONLY SECURE, NON-DETACHABLE PARTS FOR HAND-HELD SUPPORTS."

    Description of Event or Problem · 1

    THE CONSUMER'S SON WAS PUSHING HER OVER A STEP AND WHEN THE REAR WHEELS CAME OFF THE STEP, THE CHAIR ALLEGEDLY COLLAPSED AND FOLDED UP. THE CONSUMER ALLEGEDLY FLIPPED FORWARD OFF THE CHAIR ONTO THE FLOOR. THE CONSUMERS SON ALLEGES THE "SEAT PART ON EACH CORNER THE X PART SITS ON 4 BRACKETS IS NOT SITTING IN THE BRACKETS". NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 Other