BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEX GENERATOR

    MDR report key: 7597629 · Received June 13, 2018

    Report

    Report Number
    1226420-2018-00167
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 17, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    PMA / PMN Number
    K143175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: #(B)(4). BRIEF DESCRIPTION OF COMPLAINT: SMOKING OBSERVED FROM GENERATOR, AS WELL AS A BURNT SMELL. INVESTIGATION CONCLUSION: THE REPORTED ISSUE WAS CONFIRMED. AFTER OPENING THE GENERATOR SERVICE FOUND A COMPONENT (C266) ON THE RF PCB WAS SUBJECTED TO AN OVERCURRENT CONDITION. DUE TO ELECTRICAL SAFETY CONCERNS, NO FUNCTIONAL TESTING WAS CARRIED OUT AT MAE. UNIT WAS RETURNED TO (B)(4) FOR REPAIR. ONCE C266 WAS REPLACED, THE GENERATOR PASSED ALL FUNCTIONAL TESTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4).: BRIEF DESCRIPTION OF COMPLAINT: SMOKING OBSERVED FROM GENERATOR, AS WELL AS A BURNT SMELL. INVESTIGATION CONCLUSION: THE REPORTED ISSUE WAS CONFIRMED. AFTER OPENING THE GENERATOR SERVICE FOUND A COMPONENT (C266) ON THE RF PCB WAS SUBJECTED TO AN OVERCURRENT CONDITION. DUE TO ELECTRICAL SAFETY CONCERNS, NO FUNCTIONAL TESTING WAS CARRIED OUT AT MAE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING INCOMING INSPECTION OF THE AEX GENERATOR, STAFF POWERED IT ON AND REPORTED SMOKING COMING FROM THE GENERATOR. THE GENERATOR WAS TURNED OFF AND THERE WAS THERE WAS NO INJURY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, PATIENT INFORMATION IS NOT APPLICABLE.

    Description of Event or Problem · 1

    DURING INCOMING INSPECTION OF THE AEX GENERATOR, STAFF POWERED IT ON AND REPORTED SMOKING COMING FROM THE GENERATOR. THE GENERATOR WAS TURNED OFF AND THERE WAS THERE WAS NO INJURY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, PATIENT INFORMATION IS NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440578 AEX GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) 40-405-1

    Patients

    Seq Age Sex Outcome Treatment
    1