BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2612423 · Received June 12, 2012

    Report

    Report Number
    1531186-2012-00384
    Date Received
    June 12, 2012
    Date of Event
    March 25, 2012
    Report Date
    June 8, 2012
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL L-3R, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS 9 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143205 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER IS A (B)(6) FEMALE, (B)(6). THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE DEALER CALLED AND STATED THAT THE CONSUMERS LYNX L-3 SCOOTER ALLEGEDLY TOOK OFF BY ITSELF, RAN INTO THE BATHROOM AND FLIPPED OVER. THE CONSUMER ALLEGEDLY SUSTAINED 2 CRACKED RIBS AND WAS IN THE HOSPITAL FOR 2 DAYS. THE SCOOTER HAS 6 FLASHING LIGHTS WHICH ALLEGEDLY INDICATES A THROTTLE ISSUE. THE DEALER DID ASSESS THE UNIT AND WAS ABLE TO DUPLICATE THE INCIDENT. THE DEALER CONTACTED OUR TECHNICAL SERVICES DEPARTMENT. THEY DID SOME TROUBLE SHOOTING AND WERE ABLE TO DETERMINE THAT THE THROTTLE NEEDED TO BE REPLACED. THE DEALER STATED THAT THEY PROVIDED THE CONSUMER WITH ANOTHER VENDOR'S UNIT AS THE CONSUMER WAS AFRAID TO CONTINUE TO USE HER OWN SCOOTER. THE CONSUMER HAS BEEN USING THIS DEVICE FOR 3 YEARS. THE PRODUCT IS BEING RETURNED TO INVACARE FOR AN INSPECTION AND EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE SCOOTER TOOK OFF BY ITSELF WHILE IN USE AND FLIPPED OVER AND IS SHOWING 6 FLASHING LIGHTS INDICATING THROTTLE FAILURE. SERIOUS INJURY 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-3R

    Patients

    Seq Age Sex Outcome Treatment
    1 75 MO Hospitalization