BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBALT VIDEO BATON

    MDR report key: 3121603 · Received May 16, 2013

    Report

    Report Number
    9615393-2013-00136
    Event Type
    Death
    Date Received
    May 16, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS PENDING RETURN OF THE DEVICE AND ANALYSIS OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE CUSTOMER WAS REMOVING THE DISPOSABLE COVER (STAT), THE VIDEO BATON BROKE AT THE CAMERA. THE CUSTOMER SAID THEY WERE HAVING TROUBLE INTUBATING BECAUSE THE COVER WAS BLOODY. THEY REMOVED THE BATON AND ATTEMPTED TO SWITCH STATS TO USE A CLEAN STAT AND VIDEO BATON ALSO BROKE. INSTEAD OF USING ANOTHER GVL TO INTUBATE, THE DOCTOR INTUBATED IN THE OLD FASHIONED WAY. THE CUSTOMER STATED THAT THE PT DID PASS AWAY BUT IT WAS NOT DUE TO THIS EQUIPMENT. THE CUSTOMER ALSO REPORTED THAT VISIBLE DAMAGE SHOWED THE VIDEO BATON BROKE OFF AND THE WIRE STICKING OUT OF THE HANDLE AND NOT INSIDE OF THE PT. THE CUSTOMER STATED THAT THE PRODUCT WAS PROBABLY A SIZE 3 STAT BECAUSE THEY USE THOSE MOST OFTEN. THIS INCIDENT RESULTED IN A DELAYED TREATMENT DURING AN EMERGENCY CARE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218015 COBALT VIDEO BATON NONE CCW VERATHON MEDICAL (CANADA) ULC. 0570-0185

    Patients

    Seq Age Sex Outcome Treatment
    1