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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

After multiple attempts, the facility reps refused to provide any further info on the pt or details of the event.The relationship of the device usage to any blood loss or asphyxiation risk could not be confirmed.Eval summary: an inspection and testing of the device showed that it was working normally.There was no problem with led brightness in comparison to another avl baton.

• Brand Name: GLIDESCOPE AVL 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 rd; burnaby, bc V5C 5A9; CA V5C 5A9
• Manufacturer Contact: adam gaines, sr specialist ; 20001 north creek pkwy; bothell, WA 98011 ; 4256295606
• MDR Report Key: 3723704
• MDR Text Key: 4330194
• Report Number: 9615393-2014-00001
• 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: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 12/05/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1