BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7566180 · Received June 4, 2018

    Report

    Report Number
    2184149-2018-00068
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    May 7, 2018
    Report Date
    August 21, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K132073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER RECEIVED A BURN AT THE LOCATION OF THE SHOCK. ONE EP-WORKMATE SCU (SIGNAL CONDITIONING UNIT) WAS RECEIVED FOR EVALUATION. CONTINUITY TESTING OF PINS 35 AND 36 SHOWED NO SHORTS. USING A TEST STANDARD SCSI CABLE, A BASIC SIGNAL ACQUISITION/QUALITY TEST WHICH INCLUDED THE BASELINE, AMPLITUDE, AND SWITCHING WERE PERFORMED AND CONFIRMED THAT THE RETURNED AMPLIFIER PERFORMED WITHIN THE FACTORY SPECIFICATIONS. AN SCU SAFETY TEST WAS RUN AND THE UNIT PASSED. 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. THE REPORTED COMPLAINT THAT THE NURSE RECEIVED AN ELECTRICAL SHOCK WHEN THE SCSI CABLE WAS TOUCHED COULD NOT BE REPRODUCED DURING THE EVALUATION.

    Description of Event or Problem · 1

    DURING AN ATRIOVENTRICULAR NODE ABLATION PROCEDURE A USER SHOCK OCCURRED. DURING THE PROCEDURE THE SIGNAL FROM THE ABLATION CATHETER WAS LOST. THE CATHETER, CABLING AND PINS LOCATIONS WERE CHANGED BUT THE ISSUE WAS NOT RESOLVED. IT WAS SUGGESTED TO CHANGE THE SCSI CONNECTOR AND WHEN THE NURSE TOUCHED THE CONNECTOR SHE RECEIVED AN ELECTRIC SHOCK. THE PROCEDURE WAS STOPPED DUE TO THIS ISSUE. THERE WERE NO ADVERSE PATIENT OR USER CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408184 EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. 09-1462-0056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other