BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER

    MDR report key: 8159369 · Received December 13, 2018

    Report

    Report Number
    2184149-2018-00200
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 21, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMMUNICATION ISSUE WAS CONFIRMED. THE RETURNED WORKMATE CLARIS AMPLIFIER WAS POWERED ON BUT NO COMMUNICATION WAS ESTABLISHED WITH THE TEST STANDARD WORKMATE CLARIS COMPUTER. THE SINGLE BOARD COMPUTER (SBC) WAS TEMPORARILY REPLACED WITH A KNOWN GOOD SBC BOARD AND SUCCESSFUL COMMUNICATION WAS ESTABLISHED WITH THE TEST STANDARD WORKMATE CLARIS COMPUTER. USING THE TEST STANDARD SBC BOARD, THE AMPLIFIER WAS RUN FOR FEW HOURS AND NO INTERRUPTED OR LOSS OF COMMUNICATION WAS OBSERVED. THE CAUSE FOR THE COMMUNICATION ISSUE AND SUBSEQUENT PROCEDURE CANCELLATION WAS DUE TO A FAULTY SINGLE COMPUTER BOARD.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REF: 2184149-2018-00201. DURING PREPARATION FOR AN EP ABLATION PROCEDURE, THE AMPLIFIER WOULD NOT COMMUNICATE WITH THE SYSTEM AND THE PROCEDURE WAS CANCELLED. THE ERROR MESSAGE, "COMMAND PACKET CONTAINS INCORRECT PARAMETERS" DISPLAYED. THE ERROR WAS ATTEMPTED TO BE CLEARED, THE SETTINGS WERE CHANGED ON THE AMPLIFIER, THE FIBER CABLE AND MEDIA CONVERTER WERE REPLACED WITH NO RESOLUTION AND THE PROCEDURE WAS RESCHEDULED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001878 WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. H700169 6311803

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other WORKMATE¿ CLARIS¿ SYSTEM COMPUTER| WORKMATE¿ CLARIS¿ SYSTEM COMPUTER