BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE COBALT AVL MONITOR

    MDR report key: 2974050 · Received February 19, 2013

    Report

    Report Number
    9615393-2013-00097
    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
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE RECEIVED THE DEVICE FOR FURTHER EVALUATION. SERVICE EVALUATED THE MONITOR AND TURNED IT ON AND OFF MULTIPLE TIMES OVER AND OVER AND NO FAILURES APPEARED. SERVICE DID NOT CONFIRM THE INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A GLIDESCOPE COBALT AVL MONITOR THAT IS INTERMITTENTLY DISPLAYING A BLANK WHITE SCREEN WHEN POWERED ON. THE CUSTOMER HAD TO POWER ON AND OFF THE MONITOR SEVERAL TIMES BEFORE THEY CAN GET A CLEAR IMAGE. ALSO, WHEN THE MONITOR WAS POWERED ON LAST TIME IT WAS SHOWING A FUZZY VIDEO IMAGE WITH LINES ACROSS THE SCREEN. DURING TROUBLE SHOOTING WITH THE CUSTOMER THE TECHNICIAN DISCONNECTED THE BATON AND POWERED THE MONITOR ON AND OFF AND THEN RECONNECTED THE BATON WITH NO ERRORS. THE TECHNICIAN INDICATED THAT THESE STEPS WERE FOLLOWED IN THE INITIAL TROUBLESHOOTING OF THE ISSUE PRIOR TO REPORTING THE INCIDENT TO THE MANUFACTURER. THE CUSTOMER WAS ORDERED TO CONNECT A SECOND BATON TO THE MONITOR AND THE ISSUE APPEARED. THERE WAS NO INJURY TO PATIENT ASSOCIATED WITH THIS INCIDENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72504 GLIDESCOPE COBALT AVL MONITOR NONE CCW VERATHON MEDICAL (CANADA) ULC 0570-0314

    Patients

    Seq Age Sex Outcome Treatment
    1