BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VULCAN GENERATORS

    MDR report key: 2903775 · Received January 9, 2013

    Report

    Report Number
    1643264-2013-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PASSED FUNCTIONAL TESTING PER PROCESS SUMMARY (B)(4) AND 24 HOUR BURN-IN. ALL FUNCTIONS PERFORM AS EXPECTED AND UNIT WAS WITHIN CALIBRATION LIMITS. NO PROBLEM FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED MODEL E-7507 GROUNDING PAD WAS PLACED ON THE NON-OPERATIVE LEG OF THE PATIENT. TOWARDS THE END OF THE PROCEDURE THEY NOTICED THE PATIENT HAD A BURN UNDER THE GROUNDING PAD THE SIZE OF THE PAD ITSELF. THEY STOPPED THE CASE AND PULLED THE GENERATOR OUT OF THE ROOM. THEY ARE SENDING THIS UNIT BACK ALONG WITH THE GROUNDING PAD AND DO NOT WANT A REPLACEMENT. CUSTOMER DID NOT KNOW WHAT PROBE WAS BEING USED. ADDITIONAL INFO CONFIRMS THE PROCEDURE WAS A RIGHT KNEE ARTHROSCOPY; THE PLACEMENT WAS ON THE THIGH; PATIENT WAS A FEMALE WEIGHT WAS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10729 VULCAN GENERATORS GENERATOR,VULCAN CE GEI SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1