MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 15-INCH MONITOR; LARYNGOSCOPE, RIGID

Model Number 0570-0404

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

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

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

The customer declined the option to have their glidescope core 15-inch monitor returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Upon verathon following up with the customer for further troubleshooting, the customer reported being unable to isolate the issue to a particular system component and declined the option to have their system returned to verathon for evaluation.No information was provided regarding the cable or video laryngoscope used with the monitor during the reported event.Review of complaint history for the reported monitor serial number (b)(6) did not identify any previous complaints reported to verathon.Trending analysis for glidescope core 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 core 15-inch monitor, the screen abruptly went black twice.It was reported that the image was restored after the cable was wiggled.Following the reported incident, the customer reported being unable to duplicate the problem or isolate the issue to a particular system component.No delay in the procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDESCOPE CORE 15-INCH 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: 18565010
• MDR Text Key: 333500129
• Report Number: 9615393-2024-00010
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006639
• UDI-Public: 010087912300663911200602
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0404
• Device Catalogue Number: 0270-1033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• 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