BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2192425 · Received August 5, 2011

    Report

    Report Number
    1525712-2011-00423
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    August 4, 2011
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL IS A TRACER T4 MECHANICAL WHEEL CHAIR AND THE SERIAL NUMBER IS UNKNOWN. THE DEVICE IS OWNED BY A HOTEL. IT IS UNKNOWN IF THE CONSUMER FULLY READ AND UNDERSTOOD INVACARE TRACER IV HEAVY DUTY/EXTRA WIDE WHEELCHAIR USER MANUAL PART NO. 1110558. THE FOLLOWING PUBLISHED INFORMATION MAY HAVE PREVENTED THIS EVENT. THE WEIGHT OF THE CONSUMER IS UNKNOWN. WHETHER THE WHEELCHAIR HAD THE HEAVY DUTY PACKAGE IS UNKNOWN. ON PAGE 11 THE WEIGHT LIMITS ARE PROVIDED - WEIGHT LIMIT 350 LBS (159 KG); HEAVY DUTY OPTION 450 LBS (205 KGS). ON PAGE 17 THERE IS A WARNING IS PROVIDED FOR THE CONSUMER REGARDING WEIGHT LIMIT: WARNING: THE TRACER IV WHEELCHAIR WITH STANDARD WHEEL PACKAGE HAS A WEIGHT LIMITATION OF 350 LBS (159 KG). THE TRACER IV WHEELCHAIR WITH THE HEAVY DUTY WHEEL PACKAGE HAS A WEIGHT LIMITATION OF 450 LBS (205 KG.). READING THE DEVICE INFORMATION IS IMPORTANT BEFORE USING THE DEVICE AND IS PROVIDED IN THE LABELING AS A WARNING ON PAGE 12 - 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 WAS FOLLOWING THE SAFETY RECOMMENDATIONS ON THE WHEEL CHAIR. INVACARE PROVIDES THIS WARNING ON PAGE 14: "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. 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." IT IS UNKNOWN IF THE CONSUMER MADE ADJUSTMENTS AFFECTING STABILITY TO THE WHEEL CHAIR. INVACARE PROVIDES THIS WARNING ON PAGE 16 FOR STABILITY: "THE SIZE/POSITION OF THE FRONT CASTERS, SIZE/POSITION OF THE REAR WHEELS, 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 SIX 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." ALTHOUGH SEAT POSITIONING STRAPS ARE NOT SEAT BELTS, THEY DO ASSIST THE CONSUMER IS STAYING IN POSITION ON THE CHAIR. ON PAGE 16 A WARNING FOR USING THESE STRAPS IS PROVIDED: "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. WITH REGARDS TO SEAT/CHEST POSITIONING STRAPS - IT IS THE OBLIGATION OF THE DME DEALER, THERAPISTS AND OTHER HEALTHCARE PROFESSIONALS TO DETERMINE IF A SEAT/CHEST POSITIONING STRAP IS REQUIRED TO ENSURE THE SAFE OPERATION OF THIS EQUIPMENT BY THE USER. SERIOUS INJURY CAN OCCUR IN THE EVENT OF A FALL FROM A WHEELCHAIR." IT IS NOT KNOWN IF THIS IS THE CORRECT WHEEL CHAIR FOR THIS CONSUMER. THIS WHEEL CHAIR IS OWNED BY A HOTEL AND NOT A HEALTH CARE FACILITY. IT IS NOT KNOWN IF A HEALTH CARE PROVIDER RECOMMENDED THIS WHEEL CHAIR FOR THIS SPECIFIC CONSUMER. INVACARE PROVIDES THIS WARNING FOR WHEEL CHAIR SELECTION ON PAGE 19: "WARNING: 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." IT IS NOT KNOWN IF THE CONSUMER WAS OVERLOADING THE WHEELCHAIR AT THE TIME OF THE EVENT. SINCE THE EVENT WAS IN A HOTEL IT IS UNKNOWN IF THE CONSUMER WAS CARRYING LUGGAGE. INVACARE PROVIDE A WARNING FOR LOADING ON PAGE 19: "WARNING: 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." IT IS UNKNOWN IF THE HOTEL MAINTAINED THE WHEEL CHAIR TIRES. ON PAGE 28 A CAUTION IS PROVIDED FOR TIRE WEAR: "AS WITH ANY VEHICLE, CHECK THE WHEELS AND TIRES PERIODICALLY FOR CRACKS AND WEAR. REPLACE IF DAMAGED." ON TIRE CHANGING INVACARE STATES ANOTHER CAUTION ON PAGE 32 - "AS WITH ANY VEHICLE, CHECK THE WHEELS AND TIRES PERIODICALLY FOR CRACKS AND WEAR. REPLACE AS RECOMMENDED. REFER TO REPLACING/REPAIRING REAR WHEEL TIRE/TUBE ON PAGE 33 OR REPLACING/REPAIRING CASTER TIRE/TUBE ON PAGE 33. PAGE 33 STATES "WARNING: REPLACEMENT OF SOLID URETHANE OR SEMI-PNEUMATIC TIRES IS NOT RECOMMENDED. IF THE SOLID URETHANE OR SEMI-PNEUMATIC TIRES NEED REPLACED, INVACARE RECOMMENDS REPLACING COMPLETE CASTER ASSEMBLY. FOR PNEUMATIC TIRES, REPLACEMENT OF THE TUBE MUST BE PERFORMED BY A QUALIFIED TECHNICIAN" THE CONDITION OF THE WHEEL CHAIR TIRES IS UNKNOWN. INVACARE DEFINES EXCESSIVE TIRE WEAR ON PAGE 28" TIRE WEAR IS EXCESSIVE IF: PNEUMATIC TIRES - THERE IS MISSING TREAD OR THE TIRES ARE BALD. URETHANE TIRES - THERE ARE CUTS, SURFACE DEFECTS OR THE TIRES ARE LOOSE ON THE RIMS. RUBBER TIRES - 30% OR MORE OF THE TIRE HAS WORN AWAY. INVACARE RECOMMENDS THAT REAR WHEEL TIRE/TUBE AND CASTER TIRE/TUBE BE REPLACED EVERY FIVE YEARS.

    Description of Event or Problem · 1

    PER IVC LEGAL, RISK MANAGEMENT FOR (B)(4) ALLEGES THE RIGHT FRONT WHEEL RUBBER BECAME DISLODGED FROM THE FRONT WHEEL FRAME WHILE THE CONSUMER WAS MANUALLY GUIDING THE WHEELCHAIR DOWN THE HALL OF THE FACILITY. THE CONSUMER ALLEGEDLY FELL TO THE FLOOR AND WAS TAKEN TO THE HOSPITAL FOR EVALUATION AND OVERNIGHT OBSERVATION. NO SPECIFIC INJURIES ARE ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN TRACER T4

    Patients

    Seq Age Sex Outcome Treatment
    1