BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE PGVL VIDEO BATON 3-4

    MDR report key: 6604399 · Received June 1, 2017

    Report

    Report Number
    9615393-2017-00096
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 8, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ELECTED TO REMOVE THE VIDEO BATON FROM USE. UPON REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SERIAL NUMBER, (B)(4), IT WAS DETERMINED THAT THE DEVICE WAS MANUFACTURED ON 12/22/2010 AND THE ONE (1) YEAR WARRANTY PERIOD HAS EXPIRED. 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. 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 PGVL VIDEO BATON 3-4, THE VIDEO MONITOR ONLY DISPLAYS "NO SIGNAL" WHEN THE VIDEO BATON IS CONNECTED. REPORTEDLY THE CUSTOMER ISOLATED THE ISSUE TO THE VIDEO BATON AND HERE WAS A TWO (2) TO THREE (3) MINUTE DELAY IN THE PROCEDURE WHILE A SECOND LARYNGOSCOPE WAS PREPARED. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386621 GLIDESCOPE PGVL VIDEO BATON 3-4 LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0185 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1