BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE VIDEO MONITOR, GVL-2000

    MDR report key: 2974098 · Received February 19, 2013

    Report

    Report Number
    9615393-2013-00101
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE RECEIVED THE DEVICE FOR FURTHER EVALUATION. THROUGH VISUAL INSPECTION OF THE LCD SERVICE CONFIRMED THAT THE IMAGE IS VERY DARK. SERVICE REPLACED THE LCD AND IMAGE IS BACK TO NORMAL. THE LCD WAS THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A PORTABLE VIDEO MONITOR, GVL-2000 SCREEN THAT IS NOT LIGHTING UP ALL THE WAY AND THE IMAGE IS VERY DARK AND DIFFICULT TO VIEW. DURING TROUBLESHOOTING OF THE REPORTED EVENT THE CUSTOMER TRIED SEVERAL BLADES WITH THE SAME MONITOR AND THE IMAGE IS THE SAME. NO INJURY TO PATIENT WAS REPORTED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72888 PORTABLE VIDEO MONITOR, GVL-2000 NONE CCW VERATHON MEDICAL (CANADA) ULC 0231-0003

    Patients

    Seq Age Sex Outcome Treatment
    1