MAUDE Adverse Event Report: VERATHON INC. GLIDESCOPE / VERATHON GLIDESCOP; LARYNGOSCOPE, RIGID

Model Number GLIDESCOPE SPECTRUM SINGLE-USE

Device Problems Display or Visual Feedback Problem (1184); Failure to Reset (1532); Failure to Shut Off (2939)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 06/30/2020

Event Type  Death  

Event Description

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).

• Brand Name: GLIDESCOPE / VERATHON GLIDESCOP
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON INC.
• MDR Report Key: 10239106
• MDR Text Key: 197922361
• Report Number: MW5095377
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GLIDESCOPE SPECTRUM SINGLE-USE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 64 YR