BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE COBALT AVL MONITOR, PACK

    MDR report key: 2972121 · Received February 15, 2013

    Report

    Report Number
    9615393-2013-00071
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED AND THE FAULTY BATTERY CHARGER WAS REPLACED. THE SERVICE REP ALSO REPLACED THE RESISTOR 132 WITH SCHOTTKY DIODE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CUSTOMER TURNED ON THE MONITOR, IT IMMEDIATELY TURNS OFF ON TIS OWN. THEY PURCHASED A BATTERY KIT FOR THE MONITOR AND REPLACED IT BUT THE MONITOR STILL HAS THE SAME PROBLEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69463 GLIDESCOPE COBALT AVL MONITOR, PACK NONE CCW VERATHON MEDICAL (CANADA) ULC. 0570-0314

    Patients

    Seq Age Sex Outcome Treatment
    1