BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER)

    MDR report key: 8047673 · Received November 7, 2018

    Report

    Report Number
    2184149-2018-00179
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    October 18, 2018
    Report Date
    January 24, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER WAS RECEIVED FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED AMPLIFIER INDICATED THE EXTERNAL CONNECTORS, SWITCHES, AND LABELS HAD NO PHYSICAL DAMAGE. IT WAS ALSO OBSERVED THAT ALL THE EXPANSION CARDS WERE FULLY SEATED AND THAT ALL THE DATA CABLES WERE SECURED. NO PHYSICAL DAMAGE WAS PRESENT ON THE EXPANSION CARDS, OR INTERNAL COMPONENTS. DURING INITIALIZATION IT WAS CONFIRMED THAT THE RETURNED AMPLIFIER PASSED THE STARTUP HARDWARE SELF-TEST AND SUCCESSFULLY INITIATED COMMUNICATIONS WITH THE WORKMATE CLARIS WORKSTATION AS ANTICIPATED. A TWENTY-FOUR-HOUR COMMUNICATION TEST WAS PERFORMED AT THE TRANSFER RATE OF APPROXIMATELY 2000 PACKETS PER SECOND. IT WAS VERIFIED THAT THE RETURNED AMPLIFIER DID NOT ENCOUNTER ERRORS OR MISSING OR DROPPED PACKETS DURING THE COMMUNICATION TEST PERFORMED. SIGNALS WERE CONSISTENTLY DISPLAYED ON THE LIVE SCREEN DURING THE EVALUATION PERIOD. THE RESULTS OF THE INVESTIGATION DETERMINED THAT THE RETURNED AMPLIFIER FUNCTIONED CORRECTLY DURING THE HARDWARE EVALUATION PERFORMED. THE ROOT CAUSE OF THE FIELD REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED AS NO COMMUNICATION INTERRUPTS OR HARDWARE RELATED ISSUES WERE IDENTIFIED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    AT THE BEGINNING OF THE PROCEDURE, THE ERROR MESSAGE "NO SIGNAL, PLEASE CHECK AMPLIFIER CONNECTION: DISPLAYED ON THE LIVE SCREEN. THE SYSTEM WAS REBOOTED, THE CONNECTIONS WERE CHECKED, AND THE FIBER OPTIC CABLE, ETHERNET CABLE, AND POWER CABLE WERE REPLACED BUT THE ISSUE REMAINED SO THE PROCEDURE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885958 EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER) PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. H700169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other