BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE CLARIS DISPLAY PLUS AMPLIFIER

    MDR report key: 9779764 · Received March 3, 2020

    Report

    Report Number
    2184149-2020-00030
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    February 13, 2020
    Report Date
    August 28, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 STANDARD WORKMATE CLARIS COMPUTER. THE AMPLIFIER WAS POWER CYCLED SEVERAL TIMES BUT NO COMMUNICATION WAS ESTABLISHED. THE SINGLE BOARD COMPUTER (SBC) WAS TEMPORARILY REPLACED WITH A KNOWN GOOD BOARD AND SUCCESSFUL COMMUNICATION WAS ESTABLISHED WITH THE TEST STANDARD WORKMATE CLARIS COMPUTER. USING THE TEST STANDARD 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. 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 THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. THE REPORTED COMPLAINT THAT THE AMPLIFIER WOULD NOT POWER ON COULD NOT BE CONFIRMED. THE AMPLIFIER WAS POWER CYCLED SEVERAL TIMES AND NO INTERRUPTED POWER WAS OBSERVED. HOWEVER, 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.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCT RETURN WAS REQUESTED BUT NOT RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE SYSTEM SERIAL NUMBER WAS PROVIDED AND THE COMPONENT SERIAL NUMBER WAS NOT. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    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 AN ELECTROPHYSIOLOGY PROCEDURE, AFTER THE PATIENT WAS PREPPED AND PUNCTURED, THE AMPLIFIER WOULD NOT TURN ON. THE ISSUE COULD NOT BE RESOLVED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244327 WORKMATE CLARIS DISPLAY PLUS AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. H700150 6581857 05415067001504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other