BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE COBALT AVL MONITOR

    MDR report key: 2972570 · Received February 15, 2013

    Report

    Report Number
    9615393-2013-00089
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS BROUGHT IN FOR REPAIR AND THE REPORTED ISSUE WAS CONFIRMED. THE BACKSHELL/INPUT CONNECTOR WILL NEED TO BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LINES THAT DISPLAYED ACROSS THE MONITOR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69403 GLIDESCOPE COBALT AVL MONITOR NONE CCW VERATHON MEDICAL (CANADA) ULC. 0570-0314

    Patients

    Seq Age Sex Outcome Treatment
    1