BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE VIDEO MONITOR, GVL-2000

    MDR report key: 2972142 · Received February 15, 2013

    Report

    Report Number
    9615393-2013-00074
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THE SERVICE REP REPLACED THE FAULTY BATTERY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY INDICATOR WAS FLASHING ORANGE AFTER PROPER CHARGING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69467 PORTABLE VIDEO MONITOR, GVL-2000 NONE CCW VERATHON MEDICAL (CANADA) ULC. 0570-0200

    Patients

    Seq Age Sex Outcome Treatment
    1