BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3013796 · Received March 20, 2013

    Report

    Report Number
    1525712-2013-02126
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    C.T.M. SHANGHAI
    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

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 1525712-2013-02126. THE FDA REGISTRATION NUMBER SHOULD HAVE BEEN 1531186 FOR DISTRIBUTED PRODUCT.

    Description of Event or Problem · 1

    DEALER STATES INTERMITTENTLY GOING INTO DRIVE LOCKOUT. DEALER WAS NOT WITH THE CHAIR TO TROUBLESHOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116266 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. SHANGHAI L-4R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other