BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER

    MDR report key: 8974100 · Received September 9, 2019

    Report

    Report Number
    2184149-2019-00164
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    August 20, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067001504
    PMA / PMN Number
    K132073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ONE WORKMATE CLARIS AMPLIFIER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE CONNECTORS, SWITCHES, AND LABELS HAD NO PHYSICAL DAMAGE. ALL OF THE MOUNTING HARDWARE WAS SECURED. THE RETURNED WORKMATE CLARIS AMPLIFIER WAS POWERED ON BUT NO COMMUNICATION WAS ESTABLISHED WITH THE TEST COMPUTER. THE SINGLE BOARD COMPUTER (SBC) WAS TEMPORARILY REPLACED WITH A KNOWN GOOD SBC BOARD AND SUCCESSFUL COMMUNICATION WAS ESTABLISHED. 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. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE REPORTED EVENT WAS DUE TO A NON-FUNCTIONAL SBC BOARD.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE AMPLIFIER SERIAL NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COMMUNICATION ISSUE AND SUBSEQUENT CANCELLATION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.¿ FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE AMPLIFIER DID NOT COMMUNICATE AS EXPECTED. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE, THE AMPLIFIER BEEPED CONTINUOUSLY AND THE CASE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770572 WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. H700150 5771555 05415067001504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other