BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7902526 · Received September 24, 2018

    Report

    Report Number
    2184149-2018-00161
    Event Type
    Injury
    Date Received
    September 24, 2018
    Date of Event
    September 5, 2018
    Report Date
    September 24, 2018
    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 · 1

    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 SIGNAL LOSS AND SUBSEQUENT PROCEDURE CANCELLATION WAS DUE TO USER ERROR.

    Description of Event or Problem · 1

    PRIOR TO AN ELECTROPHYSIOLOGICAL EXPLORATION PROCEDURE, NO SIGNAL WAS NOTED ON THE SYSTEM AND THE PROCEDURE WAS CANCELLED. THE JUNCTION BOX AND CABLES WERE REPLACED WITH NO RESOLUTION. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR A LATER DATE. THE PATIENT WAS IN THE ROOM BUT WAS NOT PREPARED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION. FURTHER TROUBLESHOOTING REVEALED THE SIGNAL LOSS WAS DUE TO USER ERROR. THE AMPLIFIER PASSED ALL FUNCTIONAL TESTS AND RETRAINING WILL BE PROVIDED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744554 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