BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER

    MDR report key: 7352301 · Received March 20, 2018

    Report

    Report Number
    2184149-2018-00042
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    February 23, 2018
    Report Date
    April 17, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A CARDIAC ABLATION PROCEDURE, FOLLOWING PREPARATION OF THE PATIENT, THERE WAS INTERMITTENT COMMUNICATION OF THE AMPLIFIER TO THE COMPUTER. THE CONNECTIONS WERE CHECKED AND THE SYSTEM WAS RESTARTED MULTIPLE TIMES, BUT RESOLUTION WAS NOT FOUND. THE PROCEDURE WAS CANCELLED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198062 WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. H700169 6114976

    Patients

    Seq Age Sex Outcome Treatment
    1 Other WORKMATE CLARIS¿ RECORDING SYSTEM