BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2718760 · Received August 29, 2012

    Report

    Report Number
    1531186-2012-00798
    Date Received
    August 29, 2012
    Report Date
    September 26, 2012
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR REPORT #1531186-2012-00798 WITH THE MANUFACTURER AS CHIEN TI ENTERPRISE CO., LTD. THE CORRECT MANUFACTURER IS C.T.M. HOMECARE PRODUCTS, INC.

    Description of Event or Problem · 1

    DEALER STATES THE SCOOTER IS NOT TURNING OFF COMPLETELY WHEN THE KEY IS DISENGAGED. NPLUGGING THE KEY SWITCH CORRECTS THE POWER PROBLEM. REPLACING INIGITION KEY SWITCH ON #(B)(4).

    Description of Event or Problem · 1

    DEALER STATES THE SCOOTER IS NOT TURNING OFF COMPLETELY WHEN THE KEY IS DISENGAGED. UNPLUGGING THE KEY SWITCH CORRECTS THE POWER PROBLEM. REPLACING INIGITION KEY SWITCH ON #(B)(4).

    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-4B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other