BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE AVL VIDEO BATON 3-4

    MDR report key: 6581441 · Received May 22, 2017

    Report

    Report Number
    9615393-2017-00084
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 24, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIDEO BATON WAS RETURNED TO VERATHON FOR EVALUATION AND WAS TESTED BY VERATHON TECHNICAL SERVICES. THE RETURNED BATON WAS ATTACHED TO A TEST MONITOR, THE VIDEO BATON DISPLAYED STATIC-LIKE COLORED LINES WHEN THE CABLE WAS MANIPULATED; THEREFORE, THE REPORTED IMAGE ISSUE WAS CONFIRMED. BASED ON THE EVALUATION OF THE VIDEO BATON, IT WAS DETERMINED THAT CUSTOMER USE OR TECHNIQUE CAUSED OR CONTRIBUTED TO THIS EVENT. UPON REVIEW OF THE DEVICE HISTORY RECORDS FOR THE VIDEO BATON, SERIAL NUMBER (B)(4), IT WAS DETERMINED THAT THE DEVICE WAS MANUFACTURED ON 06/17/2011 AND THE ONE (1) YEAR WARRANTY PERIOD HAS EXPIRED. AS THE DEVICE IS AT ITS END OF LIFE AND NO REPAIRS ARE AVAILABLE FOR THE VIDEO BATON, THE RETURNED VIDEO BATON WAS SCRAPPED AND THE CUSTOMER ELECTED TO REPLACE THE GLIDESCOPE AVL 3-4 VIDEO BATON WITH A NEW DEVICE. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE AVL 3-4 VIDEO BATON, THERE WAS NO IMAGE ON THE SCREEN. REPORTEDLY THE CUSTOMER NARROWED THE VIDEO ISSUE DOWN TO THE VIDEO BATON. A THREE (3) MINUTE DELAY IN THE PROCEDURE WAS REPORTED, WHILE PREPARING ANOTHER GLIDESCOPE SYSTEM. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364234 GLIDESCOPE AVL VIDEO BATON 3-4 LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0313 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1