BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDESCOPE / VERATHON GLIDESCOP

    MDR report key: 10239106 · Received July 6, 2020

    Report

    Report Number
    MW5095377
    Event Type
    Death
    Date Received
    July 6, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 1, 2020
    Manufacturer
    VERATHON INC.
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SOFTWARE FAILURE OF GLIDESCOPE VIDEO LARYNGOSCOPE DURING INTUBATION ATTEMPT ON CARDIAC ARREST PATIENT. LARGE ERROR BOX DISPLAYED IN CENTER OF SCREEN INTERFERING WITH VIEW OF VOCAL CORDS MAKING IT IMPOSSIBLE TO INTUBATE PATIENT SUCCESSFULLY. ATTEMPTS MADE TO REBOOT GLIDESCOPE, BUT FAILED AS UNIT WOULD NOT SHUT OFF OR REBOOT. ATTEMPTS TO INTUBATE WITH ERROR ON SCREEN WHILE STAFF LOOKED FOR ALTERNATIVE INTUBATION LARYNGOSCOPE FAILED DESPITE TRYING TO POSITION VIEW OF VOCAL CORDS ABOVE AND TO THE LEFT OF THE ERROR MESSAGE ON THE SCREEN. THIS RESULTED IN HIGHLY SUBOPTIMAL POSITIONING OF SCOPE ABOVE VOCAL CORDS AND MADE INTUBATION IMPOSSIBLE. UNABLE TO INTUBATE AND SECURE/PROTECT AIRWAY. RESORTED TO BAGGING ONLY AS NO OTHER LARYNGOSCOPE READILY AVAILABLE. PATIENT EXPIRED FROM HER CARDIAC ARREST. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695299 GLIDESCOPE / VERATHON GLIDESCOP LARYNGOSCOPE, RIGID CCW VERATHON INC. GLIDESCOPE SPECTRUM SINGLE-USE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| L