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

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

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

Event Type  Death  

Event Description

Ref # imp (b)(4).

Manufacturer Narrative

A return authorization has been set up for the hospital to return the glidescope and stat to verathon.The glidescope unit will be evaluated once it is returned.Add'l device component: gvl 4 stat (0270-0628).

• 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 MEDICAL ULC.; 2227 douglas road; burnaby, bc V5C 5A9; CA V5C 5A9
• Manufacturer Contact: adam gaines, sr. complaint spe ; 20001 north creek parkway; bothell, WA 98011 ; 4256295606
• MDR Report Key: 3786220
• MDR Text Key: 19765975
• Report Number: 9615393-2014-00013
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Type of Report: Initial

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?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1