MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE AVL MONITOR; LARYNGOSCOPE, RIGID

Model Number 0570-0304

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

The customer was unable to have their glidescope avl monitor returned to verathon for evaluation due to this device reaching its end-of-life date.Since the device was not returned to verathon the cause could not be determined.No information was provided regarding the cable or laryngoscope used with the glidescope avl monitor during the reported incident.Review of complaint history for the video monitor serial number (b)(6) did not identify any previous complaints reported to verathon.Trending analysis for the glidescope avl monitors does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

A customer reported that during a patient procedure, using a glidescope avl monitor, the connected cable had a loose connection and resulted in the screen going blank intermittently.The procedure was completed using a backup video laryngoscope which was made available in an unspecified amount of time.No delay in the procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE AVL MONITOR
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 17644844
• MDR Text Key: 323045571
• Report Number: 9615393-2023-00161
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0304
• Device Catalogue Number: 0570-0314
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1