MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE COBALT VIDEO BATON 3-4; VIDEO LARYNGOSCOPE

Model Number 0570-0185

Device Problems Improper or Incorrect Procedure or Method (2017); Optical Problem (3001); Device Handling Problem (3265)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918)

Event Date 03/20/2014

Event Type  Death  

Event Description

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.

• Brand Name: GLIDESCOPE COBALT VIDEO BATON 3-4
• Type of Device: VIDEO LARYNGOSCOPE
• Manufacturer (Section D): VERATHON MEDICAL ULC; burnaby, bc ; CA
• Manufacturer (Section G): VERATHON INCORPORATED; 21222 30th drive se, ste. 120; bothell WA 98021 701
• Manufacturer Contact: 21222 30th drive se, ste. 120; bothell, WA 98021-7012
• MDR Report Key: 3786230
• MDR Text Key: 4438639
• Report Number: 3022472-2014-00007
• Device Sequence Number: 1
• Product Code: CCW
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2014,03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0570-0185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2014
• Distributor Facility Aware Date: 03/25/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death