BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE AVL VIDEO BATON 3-4

    MDR report key: 6586583 · Received May 23, 2017

    Report

    Report Number
    9615393-2017-00088
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Date of Event
    May 1, 2017
    Report Date
    May 1, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SERIAL NUMBER, (B)(4), IT WAS DETERMINED THAT THE DEVICE WAS MANUFACTURED ON 03/21/2011 AND THE ONE (1) YEAR WARRANTY PERIOD HAS EXPIRED. THIS IS AN INITIAL REPORT AND THE PRODUCT HAS NOT YET BEEN RECEIVED FOR EVALUATION. SHOULD THE DEVICE BE RETURNED, THE DEVICE EVALUATION DATA WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE AVL 3-4 VIDEO BATON, THE IMAGE WOULD CUT IN AND OUT. 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
    367065 GLIDESCOPE AVL VIDEO BATON 3-4 LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0313 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1