BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE COBALT AVL BATON 3-4

    MDR report key: 2974055 · Received February 19, 2013

    Report

    Report Number
    9615393-2013-00098
    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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE RECEIVED THE RETURNED DEVICE. SERVICE CONFIRMED THE REPORTED INCIDENT. A REPLACEMENT OF THE DEVICE WAS ISSUED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A GLIDESCOPE COBALT AVL BATON 3-4 THAT IS CAUSING A BLUE HAZE ACROSS THE TOP OF THE SCREEN. THE CUSTOMER TRIED ANOTHER BATON WITH THE MONITOR AND THE ISSUE DID NOT REOCCUR. THE DEVICE WAS RETURNED FOR FURTHER EVALUATION. NO PATIENT INJURY WAS REPORTED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72439 GLIDESCOPE COBALT AVL BATON 3-4 NONE CCW VERATHON MEDICAL (CANADA) ULC. 0570-0313

    Patients

    Seq Age Sex Outcome Treatment
    1