BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE AVL VIDEO BATON 3-4

    MDR report key: 6587654 · Received May 24, 2017

    Report

    Report Number
    9615393-2017-00090
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Date of Event
    April 28, 2017
    Report Date
    May 3, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY BIOMEDICAL ENGINEER STATED THAT THE VIDEO BATON HAS BEEN REMOVED FROM USE AND DISCARDED. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED LOSS OF IMAGE COULD NOT BE DETERMINED. UPON REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SERIAL NUMBER, (B)(4), IT WAS DETERMINED THAT THE DEVICE WAS MANUFACTURED ON (B)(6) 2015 AND THE ONE (1) YEAR WARRANTY PERIOD HAS EXPIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE AVL VIDEO BATON 3-4, THERE WAS NO IMAGE. REPORTEDLY A SECOND GLIDESCOPE SYSTEM WAS PREPARED AND USED, HOWEVER NO DELAY IN THE PROCEDURE WAS REPORTED. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369263 GLIDESCOPE AVL VIDEO BATON 3-4 LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0313 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1