BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL

    MDR report key: 8191304 · Received December 21, 2018

    Report

    Report Number
    2184149-2018-00209
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    December 6, 2018
    Report Date
    May 3, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067003126
    PMA / PMN Number
    K151911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE REPORTED COMPLAINT OF LOSS OF COMMUNICATION WAS CONFIRMED. AS RECEIVED, THE RETURNED EP-WORKMATE SCU POWERED ON BUT NO COMMUNICATION WAS ESTABLISHED DUE TO AN UNSEATED SINGLE BOARD COMPUTER (SBC) BOARD. THE DISPLACED BOARD WAS PROPERLY SEATED AND SUCCESSFUL COMMUNICATION WAS RESTORED. THE COMMUNICATION TEST WAS RUN FOR SEVERAL HOURS AND NO INTERRUPTED OR LOSS OF COMMUNICATION WAS OBSERVED. THE REPORTED COMMUNICATION ISSUE AND SUBSEQUENT PROCEDURE CANCELLATION WAS DUE TO THE UNSEATED SINGLE BOARD COMPUTER (SBC).

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED SELF TEST ISSUE AND SUBSEQUENT PROCEDURE CANCELLATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PRIOR TO THE PROCEDURE, THE AMPLIFIER WAS EMITTING A BEEPING TONE THAT COULD NOT BE RESOLVED AND THE PROCEDURE WAS CANCELLED. TROUBLESHOOTING WAS ATTEMPTED WITH NO RESOLUTION AND THE PROCEDURE WAS RESCHEDULED. THE PATIENT WAS NOT PREPARED BUT WAS IN THE ROOM AT THE TIME OF CANCELLATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031325 EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. 09-1462-0056 05415067003126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other