BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYANT

    MDR report key: 7040304 · Received November 17, 2017

    Report

    Report Number
    7040304
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 8, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TAH CASE VOYANT OPEN FUSION DEVICE STARTED ALARMING "RE-ACTIVATE". CHECKED GENERATOR. ATTEMPTED TO USE AFTER AND RECEIVED ANOTHER ALARM "RE-ACTIVATE". HANDED OFF DEVICE. OPENED NEW DEVICE. CASE COMPLETED WITHOUT FURTHER INCIDENCE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820102 VOYANT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES CORP. EB040 1306009

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR