BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSEI X

    MDR report key: 3394818 · Received September 19, 2013

    Report

    Report Number
    3006026430-2013-00001
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    August 20, 2013
    Report Date
    September 19, 2013
    Manufacturer
    HANSEN MEDICAL, INC.
    Product Code
    DXX
    PMA / PMN Number
    K102168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HANSEN MEDICAL INC. FIELD SERVICE PERSONNEL CONCLUDED THAT THE E-STOP SWITCH OR CABLE WAS POTENTIALLY SUSCEPTIBLE TO INTERMITTENT CONTACT. FIELD SERVICE PERSONNEL REPLACED THE E-STOP BUTTON. AFTER REPLACEMENT, THE SYSTEM PASSED ALL REQUIRED TESTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A SYSTEM E-STOP EVENT OCCURRED AND THAT THE CUSTOMER DID NOT TOUCH THE E-STOP SWITCH. CUSTOMER RESET SYSTEM FOLLOWING STANDARD PROCEDURE. CASE CONTINUED AND TREATMENT CONCLUDED SUCCESSFULLY. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473432 SENSEI X STEERABLE CATHETER CONTROL SYSTEM DXX HANSEN MEDICAL, INC. 02057 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK