BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 4734922 · Received April 28, 2015

    Report

    Report Number
    1717344-2015-00299
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 23, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION DID NOT IDENTIFY ANYTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION FOUND THAT THE UNIT FUNCTIONS NORMALLY AND WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT : (B)(6) 2015.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INCIDENT WAS NOT RELATED TO OUR DEVICE. ADDITIONAL QUESTIONS IN REGARD TO THE CLINICAL DATA WERE ASKED, AND THE DOCTOR HAS NOT PROVIDED ANY INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE GENERATOR HAD HIGH NOISE TONES AND GETTING LOUDER BEFORE ALARMING ERROR CODE E306. SHORTLY FOLLOWING THE GENERATED ERROR, THE PULSE RATE OF THE PATIENT DECREASED RAPIDLY, AND WENT INTO CARDIOPULMONARY ARREST. THE PATIENT WAS RESUSCITATED BY CARDIAC MASSAGE. THE GENERATOR WAS REPLACED WITH ANOTHER FORCETRIAD UNIT. (BC201504-0804) 10 MINUTES FOLLOWING THE REPLACEMENT OF THE UNIT, VENTRICULAR TACHYCARDIA OCCURRED. CARDIAC MASSAGE WAS GIVEN TO THE PATIENT AGAIN. THE PATIENT RECUPERATED TO A STABLE STATUS. THE PROCEDURE WAS COMPLETED WITH THE SECOND GENERATOR UNIT BUT THE PADS AND PENCILS WERE REPLACED. THE PROCEDURE WAS DELAYED 5 HOURS DUE TO THE EVENTS. THE PATIENT IS RECOVERING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279462 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP FORCETRIAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening