BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER

    MDR report key: 8225931 · Received January 8, 2019

    Report

    Report Number
    2184149-2019-00005
    Event Type
    Injury
    Date Received
    January 8, 2019
    Date of Event
    December 18, 2018
    Report Date
    February 8, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067001696
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMMUNICATION ISSUE WAS CONFIRMED. 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 AND THE AMPLIFIER PERFORMED WITHIN THE FACTORY SPECIFICATIONS. THE REPORTED COMMUNICATION ISSUE AND SUBSEQUENT PROCEDURE CANCELLATION WAS DUE TO A NON-FUNCTIONAL SBC BOARD.

    Description of Event or Problem · 1

    DURING AN ELECTIVE RIGHT ATRIAL FLUTTER PROCEDURE, NO SIGNALS WOULD DISPLAY FROM THE AMPLIFIER AND THE PROCEDURE WAS CANCELLED. THE CONNECTIONS WERE VERIFIED AND THE SYSTEM WAS REBOOTED WITH NO RESOLUTION AND THE PROCEDURE WAS RESCHEDULED FOR THE SAME DAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21024 WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. H700169 6673177 05415067001696

    Patients

    Seq Age Sex Outcome Treatment
    1 Other