BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8290135 · Received January 30, 2019

    Report

    Report Number
    2184149-2019-00012
    Event Type
    Injury
    Date Received
    January 30, 2019
    Date of Event
    January 11, 2019
    Report Date
    February 15, 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

    ONE EP-WORKMATE SIGNAL CONDITIONING UNIT WAS RECEIVED FOR EVALUATION. THE EP-WORKMATE SCU POWERED ON AND SUCCESSFULLY ESTABLISHED COMMUNICATION WITH THE TEST STANDARD EP-WORKMATE (DWS) SYSTEM AS EXPECTED. 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. COMMUNICATION TEST WAS RUN FOR SEVERAL HOURS AND NO LOSS OR INTERRUPTED COMMUNICATION WAS OBSERVED. THE REPORTED AMPLIFIER ERROR AND SUBSEQUENT CANCELLATION COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CANCELLATION OCCURRED DUE TO AN AMPLIFIER ERROR. WHEN THE PATIENT WAS IN THE OPERATING ROOM, THE AMPLIFIER WAS DISPLAYING AN ALERT ALONG WITH AN AUDIBLE NOISE. 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
    84095 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