BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC ABLATION GENERATOR

    MDR report key: 772661 · Received August 17, 2006

    Report

    Report Number
    2030404-2006-00007
    Event Type
    Malfunction
    Date Received
    August 17, 2006
    Date of Event
    March 16, 2006
    Report Date
    August 8, 2006
    Manufacturer
    IRVINE BIOMEDICAL, INC. (IBI)
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    [NOTE: THERE WAS SOME CONFUSION IN THE DATE REPORTED TO THE MFR. THE INITIAL COMPLAINT DID NOT CONTAIN INFO AS DESCRIBED IN SECTION A5, WHICH WAS LATER RECEIVED AND CONFIRMED ON 7/17/06}. TO SIMULATE THE USER ENVIRONMENT, A SIMULATED ABLATION BENCH TESTING WAS PERFORMED USING A PORCINE HEART SAMPLE IN A 37 DEGREE SALINE BATH. THE GENERATOR WAS SET TO THE SAME SETTINGS AS USED IN THE CASE (70 WATT POWER, 65 DEGREE TEMPERATURE, 120 SECONDS). ELECTRICAL ENERGY WAS DELIVERED AT THE DISTAL TIP AS EXPECTED, HOWEVER, A SECONDARY DELIVERY OF ELECTRICAL ENERGY ALSO OCCURRED AT THE 3RD BAND RESULTING IN DISCOLORATION OF THE TISSUE DISTINCTLY DIFFERENT IN APPEARANCE WITH THAT OF THE TIP. INVESTIGATION FOUND A DEFECTIVE COMPONENT BOARD IN THE GENERATOR. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. ALL BOARD COMPONENTS AND GENERATORS IN INVENTORY HAVE BEEN INSPECTED WITH NO EVIDENCE OF DEFECTIVE BOARDS. THIS IS AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ELECTRICAL ENERGY WAS DELIVERED TO A PT WHO REQUIRED CARDIOVERSION. NO LONG TERM ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC ABLATION GENERATOR RF GENERATOR DRF IRVINE BIOMEDICAL, INC. (IBI) 85512 37468

    Patients

    Seq Age Sex Outcome Treatment
    1 *