BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL

    MDR report key: 7761424 · Received August 8, 2018

    Report

    Report Number
    2184149-2018-00124
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    July 16, 2018
    Report Date
    August 28, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067003119
    PMA / PMN Number
    K151911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED EP-WORKMATE AMPLIFIER WOULD NOT POWER ON. THE POWER SUPPLY WAS TEMPORARILY REPLACED WITH A TEST STANDARD POWER SUPPLY AND NORMAL POWER WAS RESTORED. 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. 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 INVESTIGATION, THE CAUSE FOR THE SPARKING AND BURNING SMELL COULD BE ATTRIBUTED TO THE NONFUNCTIONAL POWER SUPPLY.

    Description of Event or Problem · 1

    PRIOR TO AN ELECTROPHYSIOLOGY PROCEDURE, THE AMPLIFIER DISPLAYED THE MESSAGE ¿NO DISPLAY - PLEASE CHECK CONNECTION¿ AND A SPARK WAS OBSERVED FOLLOWED BY A BURNING SMELL. THE AMPLIFIER WAS POWER CYCLED AND A LOUD CONTINUOUS BEEPING SOUND CAME FROM THE AMPLIFIER. THE PATIENT WAS MOVED TO ANOTHER ROOM AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605276 EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL, INC. 09-1463-0120 05415067003119

    Patients

    Seq Age Sex Outcome Treatment
    1