BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMG ADVANCED GENERATOR

    MDR report key: 2905424 · Received January 9, 2013

    Report

    Report Number
    1033422-2013-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 11, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF GENERATOR IS PENDING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE EVALUATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT AS THE ANALYSIS OF THE UNIT IS STILL IN PROGRESS. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM THE (B)(6), STATING, "WE HAVE HAD A GENERATOR THAT HAS APPARENTLY BLOWN. THERE IS A H02 ERROR CODE SHOWING. THIS OCCURRED AFTER THE MACHINE WOULD NOT POWER ON AND AFTER THE FUSE WAS CHANGED. THE STAFF ALSO MENTIONED IT WAS SMOKING AND THEY COULD SMELL SMOKE TOO." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10412 PMG ADVANCED GENERATOR RADIOFREQUENCY GENERATOR GXD KIMBERLY-CLARK HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1