BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE CLARIS SYSTEM

    MDR report key: 11143175 · Received January 8, 2021

    Report

    Report Number
    2184149-2021-00006
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    December 11, 2020
    Report Date
    March 31, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067001238
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    ONE WORKMATE CLARIS AMPLIFIER WITH PN 100084422 AND SN 15870458 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 A FEW HOURS, AND NO INTERRUPTION 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, THE SYSTEM HAD DID NOT START. THE AMPLIFIER AND CONNECTIONS WERE CHECKED, BUT THE ISSUE REMAINED. THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38007 WORKMATE CLARIS SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. H700123 5350321 05415067001238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other