BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE AVL MONITOR

    MDR report key: 5634975 · Received May 5, 2016

    Report

    Report Number
    9615393-2016-00100
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Date of Event
    February 26, 2015
    Report Date
    March 30, 2015
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS RECEIVED FOR EVALUATION AND THE REPORTED FAILURE WAS CONFIRMED. TECH SERVICES DETERMINED THAT THE FAULT WAS AN ELECTRICAL CONNECTION FAILURE SO THEY REPLACED THE FAULTY INPUT CONNECTOR. THE DEVICE WAS RETURNED TO THE CUSTOMER. ADDITIONAL PART USED: GLIDESCOPE AVL VIDEO BATON 1-2; CATALOG: 0570-0312; SN: (B)(4). 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, THERE WAS AN INTERMITTENT PICTURE AS WELL AS LINES ACROSS THE PICTURE. THE DEVICE WAS VERY SENSITIVE TO MOVEMENT. 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
    289307 GLIDESCOPE AVL MONITOR LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0314

    Patients

    Seq Age Sex Outcome Treatment
    1