BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE CLARIS SYSTEM AMPLIFIER

    MDR report key: 10617670 · Received October 1, 2020

    Report

    Report Number
    2184149-2020-00165
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 26, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067001696
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 COMMUNICATION WAS OBSERVED. 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.

    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 WITH THE PATIENT ON THE TABLE, AN "AMPLIFIER DISCONNECTED" ERROR WAS NOTED AND THE CASE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076061 WORKMATE CLARIS SYSTEM AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. H700169 6472429 05415067001696

    Patients

    Seq Age Sex Outcome Treatment
    1