BEUDAMED
    FDA Adverse Event Summary report: N

    ICC 300

    MDR report key: 2063389 · Received April 12, 2011

    Report

    Report Number
    2063389
    Date Received
    April 12, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ERBE USA, INC
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE OR REPORTED A POSSIBLE MACHINE MALFUNCTION AND THERE WERE 2 BLACKENED SPOTS VISIBLE ON THE ESU ELECTROSURGICAL UNIT GROUNDING PAD. THE ESU UNIT WAS BROUGHT DOWN TO BIOMEDICAL ENGINEERING FOR A COMPLETE INVESTIGATION. THE EQUIPMENT WAS THEN INSPECTED AND ERROR LOG WAS REVIEWED FOR POSSIBLE ERROR CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE ERROR.ALL TEST BOTH VISUAL AND PERFORMANCE WERE CONDUCTED. THE BIOMED TECH FOUND ONE AREA OF CONCERN THAT MAY HAVE CONTRIBUTED TO THE BURNS. THE NESSY OR RESISTANCE MONITORING WAS OUT OF TOLERANCE. THE CIRCUIT WAS RECALIBRATED AND TESTED FOR SEVERAL HOURS AND THE UNIT WAS FOUND TO BE IN STABLE OPERATING CONDITION AND FUNCTIONING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICC 300 ELECTROSURGICAL UNIT GEI ERBE USA, INC ICC 300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR NO OTHER THERAPIES