BEUDAMED
    FDA Adverse Event Death Summary report: N

    GS AVL/GVM MONITOR

    MDR report key: 5007393 · Received August 13, 2015

    Report

    Report Number
    9615393-2015-00062
    Event Type
    Death
    Date Received
    August 13, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 3, 2015
    Manufacturer
    VERATHON MEDICAL ULC.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THIS PRODUCT HAS NOT BEEN RECEIVED BACK FOR EVALUATION. THIS PRODUCT HAS NOT BEEN RECEIVED BACK FOR EVALUATION AT THE TIME OF THIS REPORT. THE PROBLEM CANNOT BE CONFIRMED. IF THE SUSPECT DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE ISSUED WITH THE RESULTS OF THE EVALUATION. ON 05/10/2013 SAFETY ALERT NOTICE C/R. NOTICE 3022472-5-07-2013-0001-C WAS ISSUED TO ALL CUSTOMERS TO PROVIDE ADDITIONAL SAFETY INFO TO REMIND USERS TO CAREFULLY EXAMINE BLADES BEFORE AND AFTER EACH USE, AND PROMPTLY REPLACE ANY THAT SHOW SIGNS OF WEAR OR DAMAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SCREEN ON THE MONITOR WAS FLICKERING DURING USE. THE PT EXPIRED DURING THE PROCEDURE, HOWEVER THE CUSTOMER REPORTED THAT IT WAS NOT CAUSED BY THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532461 GS AVL/GVM MONITOR VIDEO LARYNGOSCOPE CCW VERATHON MEDICAL ULC. GS AVL/GVM MONITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death