BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2262250 · Received September 23, 2011

    Report

    Report Number
    1525712-2011-00541
    Date Received
    September 23, 2011
    Report Date
    September 23, 2011
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    "RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS SCOOTER. LYNX L-3 AND LYNX L-4 SCOOTERS USER MANUAL - PART NO. 1143205 REV A (JUN/06) PROVIDES THE FOLLOWING GUIDELINES. IT IS UNKNOWN IF THE CONSUMER OR DEALER HAS READ AND FULLY UNDERSTANDS THE USER MANUAL. THE FOLLOWING WARNINGS, CAUTIONS AND INSTRUCTIONS ARE PROVIDED TO PREVENT OVERHEATING OF THE MOTORS. IT IS UNKNOWN IF THE SCOOTER HAS BEEN EXPOSED TO MOISTURE. THE FOLLOWING WARNING IS PROVIDED ON PAGE 8: "WARNING -SCOOTERS SHOULD BE EXAMINED DURING MAINTENANCE FOR SIGNS OF CORROSION (WATER EXPOSURE, INCONTINENCE, ETC.). ELECTRICAL COMPONENTS DAMAGED BY CORROSION SHOULD BE REPLACED IMMEDIATELY. SCOOTERS THAT ARE USED BY INCONTINENT USERS AND/OR ARE FREQUENTLY EXPOSED TO WATER MAY REQUIRE REPLACEMENT OF ELECTRICAL COMPONENTS MORE FREQUENTLY. IN ADDITION, ON PAGE 14 THE FOLLOWING LIST OF INSTRUCTIONS ARE PROVIDED: "RAIN TEST" "INVACARE HAS TESTED ITS POWERED SCOOTERS IN ACCORDANCE WITH ISO 7176 "RAIN TEST." THIS PROVIDES THE END USER OR HIS/HER ATTENDANT SUFFICIENT TIME TO REMOVE HIS/HER POWER POWERED SCOOTER FROM A RAIN STORM AND RETAIN POWERED SCOOTER OPERATION." "DO NOT LEAVE THE POWERED SCOOTER IN A RAIN STORM OF ANY KIND." "DO NOT USE THE POWERED SCOOTER IN A SHOWER." "DO NOT LEAVE THE POWERED SCOOTER IN A DAMP AREA FOR ANY LENGTH OF TIME." "DIRECT EXPOSURE TO RAIN OR DAMPNESS WILL CAUSE THE SCOOTER TO MALFUNCTION ELECTRICALLY AND MECHANICALLY; MAY CAUSE THE POWERED SCOOTER TO PREMATURELY RUST." "CHECK TO ENSURE THAT ALL ELECTRICAL CONNECTIONS ARE SECURE AT ALL TIMES." THE WEIGHT OF THE CONSUMER IS UNKNOWN. IT IS UNKNOWN IF THE CONSUMER HAD ADDITIONAL LOADING ON THE DEVICE TO CAUSE THE MOTORS TO BECOME HOT. THE FOLLOWING WEIGHT LIMIT IS PROVIDED IN A CHART ON PAGE 9: "MAXIMUM WEIGHT LIMITATION 250 LBS." IT IS UNKNOWN IF ADDITIONAL MEDICAL DEVICES WERE ON BOARD THE SCOOTER AT THE TIME THE MOTORS BECAME HOT. THE FOLLOWING WARNING IS PROVIDED ON PAGE 11: "DO NOT CONNECT ANY MEDICAL DEVICES SUCH AS VENTILATORS, LIFE SUPPORT MACHINES, ETC., TO THE BATTERY. THIS COULD CAUSE UNEXPECTED FAILURE OF THE DEVICE AND THE POWERED SCOOTER." IT IS UNKNOWN IF THE MOTORS WERE EXPOSED TO HEAT PRIOR TO THE DETERMINATION THAT THE MOTORS WERE HOT. THE FOLLOWING INFORMATION IS PROVIDED ON PAGE 13: "AVOID STORING OR USING THE SCOOTER NEAR OPEN FLAME OR COMBUSTIBLE PRODUCTS. SERIOUS INJURY OR DAMAGE TO PROPERTY MAY RESULT." IT IS UNKNOWN IF ALL ELECTRICAL CONNECTIONS WERE SECURE AT THE TIME OF THE HOT MOTORS. THE FOLLOWING INFORMATION IS PROVIDED ON PAGE 13: "CHECK TO ENSURE THAT ALL ELECTRICAL CONNECTIONS ARE SECURE AT ALL TIMES." IT IS UNKNOWN IF THE CORRECT BATTERY WAS BEING USED AT THE TIME OF THE HOT MOTORS. THE FOLLOWING CAUTION IS PROVIDED ON PAGE 37: "CAUTION: FAILURE TO USE THE CORRECT BATTERY SIZE AND/OR VOLTAGE MAY CAUSE DAMAGE TO THE POWERED SCOOTER AND GIVE UNSATISFACTORY PERFORMANCE." A FAIL SAFE CIRCUIT BREAKER IS ON THE DEVICE FOR ISSUES THAT COULD AFFECT THE MECHANICAL/ELECTRICAL COMPONENTS. THE FOLLOWING WARNING IS PROVIDED ON PAGE 41: "WARNING - IF THE CIRCUIT BREAKER TRIPS REPEATEDLY, IMMEDIATELY UNPLUG CHARGER AND CONTACT DEALER OR A QUALIFIED TECHNICIAN."

    Description of Event or Problem · 1

    THE DEALER ALLEGES THE MOTORS ARE GETTING HOT. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC L-4R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other