BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER)

    MDR report key: 7822352 · Received August 28, 2018

    Report

    Report Number
    2184149-2018-00139
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    August 2, 2018
    Report Date
    November 29, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF SIGNAL LOSS WAS CONFIRMED. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE EVALUATION PERFORMED, THE RETURNED AMPLIFIER INTERMITTENTLY LOST COMMUNICATION WITH THE WORK MATE CLARIS COMPUTER DUE TO AN INTERMITTENT SINGLE BOARD COMPUTER (SBC). USING A TEST STANDARD SBC, THE COMMUNICATION TESTS WAS PERFORMED FOR SEVERAL HOURS AND NO INTERRUPTED OR LOSS OF COMMUNICATION WAS OBSERVED. THE REPORTED FILED EVENT WAS ISOLATED TO AN INTERMITTENT SBC BOARD.  THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THERE WAS SIGNAL LOSS AND THE PROCEDURE WAS CANCELLED. CONNECTION WAS NOT SUCCESSFUL TO THE AMPLIFIER. THE FIBER OPTIC CABLE WAS REPLACED WITH NO RESOLUTION.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THERE WAS SIGNAL LOSS AND THE PROCEDURE WAS CANCELLED. CONNECTION WAS NOT SUCCESSFUL TO THE AMPLIFIER. THE FIBER OPTIC CABLE WAS REPLACED WITH NO RESOLUTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663830 EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER) COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. H700150 6429659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other