BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS PGVL VIDEO MONITOR

    MDR report key: 5632788 · Received May 4, 2016

    Report

    Report Number
    9615393-2016-00199
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION AT THE TIME OF THIS REPORT. THE PROBLEM CANNOT BE CONFIRMED. IF THE SUSPECT DEVICE IS RETURNED A SUPPLEMENTAL REPORT WILL BE ISSUED WITH THE RESULTS OF THE EVALUATION. THIS MDR IS BEING FILED AS RESULT OF A RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GS PGVL VIDEO MONITOR, THE MONITOR WAS NOT WORKING; NOT SHOWING ANYTHING ON THE SCREEN. THEY HAD A SECOND GVL AND THEY WERE ABLE TO PINPOINT THE PROBLEM TO THE MONITOR. NO DELAY IN THE PROCEDURE OR USE OF A BACK-UP DEVICE WAS REPORTED. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287662 GS PGVL VIDEO MONITOR LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0231-0003

    Patients

    Seq Age Sex Outcome Treatment
    1