BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EA020, VOYANT GENERATOR, 1/BX

    MDR report key: 9282316 · Received November 5, 2019

    Report

    Report Number
    2027111-2019-00625
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Report Date
    December 6, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    10060795137601
    PMA / PMN Number
    K182244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE EVENT UNIT, WHICH CONFIRMED THAT THE VOLUME OF THE GENERATOR WAS LOW. BASED ON THE CONDITION OF THE RETURNED UNIT, THE REPORTED EVENT WAS CAUSED BY A FAULTY SPEAKER. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    NAME OF PROCEDURE: NI. ACTIVATION TONES ARE LOW, NOT WORKING PROPERLY. DEVICE WILL BE RETURNED. PATIENT STATUS: NI. INTERVENTION: NI.

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    NAME OF PROCEDURE: NI. ACTIVATION TONES ARE LOW, NOT WORKING PROPERLY. DEVICE WILL BE RETURNED. PATIENT STATUS: NI. INTERVENTION: NI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076776 EA020, VOYANT GENERATOR, 1/BX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES EA020 1362452 10060795137601

    Patients

    Seq Age Sex Outcome Treatment
    1