BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE CLARIS DISPLAY PLUS AMPLIFIER

    MDR report key: 10395209 · Received August 12, 2020

    Report

    Report Number
    2184149-2020-00122
    Event Type
    Injury
    Date Received
    August 12, 2020
    Report Date
    September 21, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067001504
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, G4, G7, H2, H3, H6. ONE WORKMATE CLARIS AMPLIFIER WAS RECEIVED FOR EVALUATION. 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 SIGNAL WAS OBSERVED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    THE RESULTS, METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    PRIOR TO THE PROCEDURE THE EKG SIGNALS WOULD NOT DISPLAY ON THE SCREEN. THE RECORDING SYSTEM AND AMPLIFIER WERE POWER CYCLED BUT THE ISSUE REMAINED. THE PATIENT WAS ALREADY IN THE PROCEDURE ROOM AND UNDER LOCAL ANESTHESIA WHEN THE CASE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860751 WORKMATE CLARIS DISPLAY PLUS AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. H700150 6207561 05415067001504

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other