BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE AVL VIDEO BATON 3-4

    MDR report key: 6537574 · Received May 2, 2017

    Report

    Report Number
    9615393-2017-00079
    Event Type
    Malfunction
    Date Received
    May 2, 2017
    Date of Event
    April 11, 2017
    Report Date
    April 11, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIDEO BATON WAS REPLACED FOR THE CUSTOMER. THE BATON WAS RETURNED TO VERATHON FOR EVALUATION. THE PRODUCT WAS RECEIVED AND TESTED BY VERATHON TECHNICAL SERVICES, THE REPORTED FLICKERING IMAGE AND THE GREEN LINES WERE CONFIRMED, WHEN THE VIDEO BATON CABLE WAS FLEXED. THERE ARE NO REPAIRS AVAILABLE FOR THE AVL VIDEO BATON, THEREFORE THE RETURNED BATON WAS SCRAPPED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE AVL VIDEO BATON 3-4, THE DISPLAY HAD GREEN LINES AND A FLICKERING OF THE IMAGE. 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
    319540 GLIDESCOPE AVL VIDEO BATON 3-4 LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0198 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1