BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 4102352 · Received August 27, 2014

    Report

    Report Number
    3006026430-2014-00004
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    May 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    HANSEN MEDICAL INC.
    Product Code
    DXX
    PMA / PMN Number
    K102168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM LOST VIDEO ON WORKSTATION CENTER MONITOR DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. FIELD SERVICE PERSONNEL CONFIGURED WORKSTATION DISPLAY RESOLUTION ON COMPUTER AND REPLACED FIBER OPTIC TX/RX CABLE. AFTER REPAIR THE SYSTEM PASSED ALL REQUIRED TESTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A SYSTEM LOST VIDEO ON WORKSTATION CENTER MONITOR DURING THE PROCEDURE. THE PROCEDURE COULD NOT BE COMPLETED USING THE SENSEIX SYSTEM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522623 NONE DXX HANSEN MEDICAL INC. 08257 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R