BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER

    MDR report key: 8743438 · Received June 28, 2019

    Report

    Report Number
    2184149-2019-00123
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 20, 2019
    Report Date
    September 9, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067001696
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE WORKMATE CLARIS AMPLIFIER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ANOMALIES. THE RETURNED WORKMATE CLARIS AMPLIFIER WAS POWERED ON AND SUCCESSFUL COMMUNICATION WAS ESTABLISHED WITH THE TEST STANDARD WORKMATE CLARIS COMPUTER. A BASIC SIGNAL ACQUISITION/QUALITY TEST WHICH INCLUDED THE SURFACE ECG, BASELINE, AMPLITUDE AND STIMULUS SWITCHING WERE PERFORMED AND CONFIRMED THAT THE RETURNED AMPLIFIER PERFORMED WITHIN THE FACTORY SPECIFICATIONS. THE AMPLIFIER STATUS WAS REVIEWED INCLUDING THE SINGLE BOARD COMPUTER (SBC) TEMPERATURE AND VOLTAGE SENSORS REVEALING NO ANOMALIES. THE AMPLIFIER WAS RUN BUT THE COMMUNICATION DROPPED AFTER FEW HOURS OF TESTING. THE SBC BOARD WAS TEMPORARILY REPLACED WITH A TEST SBC BOARD AND THE COMMUNICATION WAS RUN FOR SEVERAL HOURS WITH NO LOSS OR DROP IN COMMUNICATION. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED EVENT. 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 FIELD EVENT WAS ISOLATED TO AN INTERMITTENT SBC BOARD.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, AN ERROR MESSAGE OCCURRED DURING INITIAL BOOT UP OF THE AMPLIFIER. THE ERROR MESSAGE WAS BYPASSED BY DOING A RE-BOOT. HALFWAY THROUGH THE CASE, THE AMPLIFIER LOST COMMUNICATION AGAIN. THE FIBER OPTIC CABLE WAS REPLACED WHICH DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS CANCELLED. THERE WERE NO CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539673 WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. 100084422 6485423 05415067001696

    Patients

    Seq Age Sex Outcome Treatment
    1 Other