BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7761709 · Received August 8, 2018

    Report

    Report Number
    2184149-2018-00118
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    July 10, 2018
    Report Date
    August 8, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE EP-WORKMATE SIGNAL CONDITIONING UNIT WAS RECEIVED FOR EVALUATION. THE EP-WORKMATE SCU POWERED ON AND INTERMITTENT COMMUNICATION WAS ESTABLISHED. THE UNIT WAS POWER CYCLED TWICE AND INTERMITTENT COMMUNICATION WAS STILL PRESENT. DUE TO THE INTERMITTENT COMMUNICATION OBSERVED, THE SINGLE BOARD COMPUTER (SBC) WAS TEMPORARILY REPLACED WITH A KNOWN GOOD SBC. 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 PERFORMED FOR SEVERAL HOURS AND NO LOSS OR INTERRUPTED COMMUNICATION WAS OBSERVED. THE REPORTED EVENT WAS ISOLATED TO AN INTERMITTENT SBC BOARD. 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 A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE A CANCELLATION OCCURRED DUE TO AMPLIFIER SIGNAL ERRORS. TO RESOLVE THE ISSUE THE SYSTEM CABLES WERE EXCHANGED, THE SYSTEM WAS RESTARTED AND THE IP ADDRESS WAS CHANGED BUT THERE WERE NO IMPROVEMENTS. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603977 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