BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE COBALT AVL MONITOR, PACK

    MDR report key: 3000154 · Received February 14, 2013

    Report

    Report Number
    9615393-2013-00060
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE RECEIVED THE DEVICE FOR FURTHER EVALUATION. SERVICE CONFIRMED THE FAILURE AND IS REPLACING THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A GLIDESCOPE COBALT AVL MONITOR VIDEO IMAGE THAT IS FLICKERING. DURING TROUBLESHOOTING, THE CUSTOMER PERFORMED A POWER CYCLING TO THE MONITOR WHICH DID NOT RESOLVE THE FLICKERING ISSUE. ALSO, A BATON AND TWO REUSABLE GVL'S WERE CONNECTED TO THE MONITOR AND THE ISSUE WAS NOT RESOLVED. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS RETURNED FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65831 GLIDESCOPE COBALT AVL MONITOR, PACK NONE CCW VERATHON MEDICAL (CANADA) ULC. 0570-0314

    Patients

    Seq Age Sex Outcome Treatment
    1