BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2222353 · Received August 25, 2011

    Report

    Report Number
    1525712-2011-00462
    Date Received
    August 25, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 24, 2011
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 PROVIDES THE FOLLOWING GUIDELINES FOR "BATTERIES." IT IS UNKNOWN IF THE CONSUMER OR DEALER HAS READ AND FULLY UNDERSTANDS THE USER MANUAL, SPECIFICALLY, AS IT PERTAINS TO THE BATTERY. THE FOLLOWING WARNINGS, CAUTIONS AND INSTRUCTIONS ARE PROVIDED TO PREVENT THE BURNING OF THE BATTERY BOX. PAGE 37 WARNING: BEFORE PERFORMING ANY MAINTENANCE ADJUSTMENT OR SERVICE, TURN POWER OFF AND REMOVE KEY FROM IGNITION. NEVER ALLOW ANY OF YOUR TOOLS AND/OR BATTERY CABLES TO CONTACT BOTH BATTERY TERMINALS AT THE SAME TIME. AN ELECTRICAL SHORT MAY OCCUR AND SERIOUS PERSONAL INJURY OR DAMAGE MAY OCCUR. THE USE OF RUBBER GLOVES IS RECOMMENDED WHEN WORKING WITH BATTERIES. DO NOT TIP THE BATTERIES. KEEP THE BATTERIES IN AN UPRIGHT POSITION. INVACARE STRONGLY RECOMMENDS THAT BATTERY INSTALLATION AND BATTERY REPLACEMENT ALWAYS BE DONE BY A QUALIFIED TECHNICIAN. ALL BATTERY TERMINALS CAPS (TWO ON THE LEFT BATTERY AND TWO ON THE RIGHT BATTERY) MUST BE INSTALLED PRIOR TO USE. PAGE 37 - CAUTION: WHEN CONNECTING THE BATTERY CABLES TO THE BATTERIES, THE BATTERY CABLES MUST BE CONNECTED TO THE BATTERY TERMINALS/POSTS AS SHOWN IN FIGURE 10.3 - OTHERWISE DAMAGE TO THE BATTERY MAY RESULT. IF THERE IS BATTERY ACID IN THE BOTTOM OF THE BATTERY BOX OR ON THE SIDES OF THE BATTERIES, APPLY BAKING SODA TO THESE AREAS TO NEUTRALIZE THE BATTERY ACID. BEFORE REINSTALLING THE EXISTING OR NEW BATTERIES, CLEAN THE BAKING SODA FROM THE BATTERY TRAY OR BATTERIES BEING SURE TO AVOID CONTACT WITH SKIN AND EYES. DETERMINE SOURCE OF CONTAMINATION. NEVER INSTALL/REINSTALL A BATTERY WITH A CRACKED OR OTHERWISE DAMAGED CASE. REMOVING THE BATTERIES. PAGE 40 INSTRUCTIONS: REMOVING THE BATTERY. REMOVE THE SEAT. REFER TO REMOVING/INSTALLING THE SEAT ON PAGE 23. REMOVE THE BATTERY BOX FROM THE SCOOTER. REFER TO REMOVING/INSTALLING THE BATTERY BOX ON PAGE 39. REMOVE THE TWELVE MOUNTING SCREWS (NOT SHOWN) THAT SECURE THE BATTERY BOX TOP TO THE BATTERY BOX (DETAIL "A" OF FIGURE 10.3). DISCONNECT THE WIRING HARNESS FROM THE BATTERIES BY HOLDING THE CONNECTORS AND PULLING THEM IN THE FOLLOWING ORDER (DETAIL "B" OF FIGURE 10.3): NEGATIVE (-) BLACK BATTERY CABLE FROM THE NEGATIVE (-) BATTERY TERMINAL ON THE LEFT BATTERY. POSITIVE (+) RED BATTERY CABLE FROM THE POSITIVE (+) BATTERY TERMINAL ON THE RIGHT BATTERY. WHITE BATTERY CABLE (JUMPER) FROM THE POSITIVE (+) BATTERY TERMINAL ON THE LEFT BATTERY AND THE NEGATIVE (-) BATTERY TERMINAL ON THE RIGHT BATTERY. REMOVE THE TAPE SECURING THE THERMAL SWITCH TO THE SIDE OF THE LEFT BATTERY. REMOVE THE BATTERIES FROM BATTERY BOX BY LIFTING THE BATTERIES OUT.

    Description of Event or Problem · 1

    THE DEALER TECH ALLEGES THE BATTERY TERMINALS CAME LOOSE AND BURNT THE BATTERY BOX AND TERMINALS. 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