BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDESCOPE COBALT VIDEO BATON 3-4

    MDR report key: 3786230 · Received April 14, 2014

    Report

    Report Number
    3022472-2014-00007
    Event Type
    Death
    Date Received
    April 14, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 25, 2014
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT OF ADVANCED AGE HAD BEEN ON VENTILATION USING AN ENDOTRACHEAL TUBE AND A VENTILATOR FOR A PERIOD OF TREATMENT, AND WHEN EXTUBATION PARAMETERS WERE ESTABLISHED THE PT WAS SUCCESSFULLY WEANED FROM VENTILATION. THE PT WAS BREATHING ADEQUATELY POST-EXTUBATION, BUT SHOW SIGNS OF WEAKENING EFFORTS AND BECAME A CANDIDATE FOR RE-INTUBATION (AN AIRWAY EXCHANGE CATHETER WAS NOT USED DURING THE TRIAL OF UNASSISTED VENTILATION). DURING AN EMERGENCY RE-INTUBATION OF THE PT, THE PHYSICIAN TRAINEE INSERTED THE GLIDESCOPE COBALT VIDEO BATON 180 DEGREES OFF FROM THE CORRECT ORIENTATION INTO THE GVL STAT. THIS WAS CONTRARY TO THE USER MANUAL INSTRUCTIONS. WHEN INSERTED CORRECTLY, THE BATON CLICKS INTO PLACE, AND THE LOGOS LINE UP. THE RESULT OF THE INCORRECT BATON INSERTION WAS DIFFICULTY WITH VISUALIZING THE AIRWAY ON THE MONITOR. THE PT SUBSEQUENTLY WENT INTO HYPOXIA-INDUCED CARDIAC ARREST, AND EXPIRED. THE ICU DIRECTOR PHYSICIAN STATED THAT THE SEVERE PT CONDITION WAS THE CAUSE OF DEATH, AND NOT THE GLIDESCOPE ISSUE SPECIFICALLY. REF # MFR 9615393-2014-00013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228388 GLIDESCOPE COBALT VIDEO BATON 3-4 VIDEO LARYNGOSCOPE CCW VERATHON MEDICAL ULC 0570-0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Death