BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE COBALT AVL MONITOR, PACK

    MDR report key: 2972119 · Received February 15, 2013

    Report

    Report Number
    9615393-2013-00069
    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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS NOT CONFIRMED. SEVERAL TESTS WERE PERFORMED OVER A THREE DAY PERIOD AND NO FAILURES APPEARED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN INTERMITTENT SHORT/LINES. THE CUSTOMER STATED THAT IF HE MOVED THE MONITOR WHILE ON THE STAND, THE SCREEN WOULD SHORT OUT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69377 GLIDESCOPE COBALT AVL MONITOR, PACK NONE CCW VERATHON MEDICAL (CANADA) ULC. 0570-0314

    Patients

    Seq Age Sex Outcome Treatment
    1