BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE CLARIS DISPLAY PLUS AMPLIFIER

    MDR report key: 10076950 · Received May 20, 2020

    Report

    Report Number
    2184149-2020-00068
    Event Type
    Injury
    Date Received
    May 20, 2020
    Date of Event
    May 19, 2020
    Report Date
    June 23, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067009777
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE WORKMATE CLARIS AMPLIFIER WAS RECEIVED FOR EVALUATION. THE AMPLIFIER WAS POWERED ON BUT NO COMMUNICATION WAS ESTABLISHED WITH THE TEST WORKMATE CLARIS COMPUTER. THE SINGLE BOARD COMPUTER (SBC) WAS TEMPORARILY REPLACED WITH A KNOWN GOOD SBC BOARD AND SUCCESSFUL COMMUNICATION WAS ESTABLISHED. USING THE TEST SBC BOARD, 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. HOWEVER, COMMUNICATION AND SIGNAL WERE RESTORED WHEN THE SUSPECTED SBC WAS REINSTALLED. 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. THE REPORTED EVENT WAS DUE TO AN INTERMITTENT SBC BOARD.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THERE WAS NO SIGNAL, THE COMPUTER FROZE AND THE PROCEDURE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541103 WORKMATE CLARIS DISPLAY PLUS AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. H700150 6187791 05415067009777

    Patients

    Seq Age Sex Outcome Treatment
    1 Other