BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE AVL MONITOR

    MDR report key: 5634676 · Received May 5, 2016

    Report

    Report Number
    9615393-2016-00058
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Date of Event
    March 10, 2015
    Report Date
    March 10, 2015
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES EVALUATED THE RETURNED PRODUCT AND CONFIRMED THE IMAGE ISSUE. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER. THE PRODUCT WAS EVALUATED FOR THE REPORTED MALFUNCTION AND THE MALFUNCTION WILL BE TRACKED AND TRENDED TO DETERMINE ANY ADDITIONAL ACTIONS. THIS MDR IS BEING FILED AS RESULT OF A RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE AVL MONITOR, WHEN ANY SCOPE WAS PLUGGED IN, ANY PRESSURE PUT ON THE FACE OF THE MONITOR CAUSED THE VIDEO TO CUT OUT. A BACK-UP AVL MONITOR WAS REPORTEDLY USED. A ONE MINUTE DELAY IN THE PROCEDURE WAS NOTED. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289186 GLIDESCOPE AVL MONITOR LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0314

    Patients

    Seq Age Sex Outcome Treatment
    1