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

Model Number	0570-0437
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope core 15-inch fhd monitor is not expected to be returned to verathon for evaluation, therefore the cause could not be determined.However, verathon followed up with the customer and they confirmed that the system was operating as intended and has been returned to service at the facility.Review of complaint history for the reported glidescope core15-inch fhd monitor serial number "(b)(6)" did not identify any previous complaints reported to verathon.Trending analysis for glidescope core fhd monitors does not identify any trends exceeding acceptable limits.Verathon confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized per the system risk assessment.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope core 15-inch fhd monitor, the screen was freezing.No delay in procedure, use of a backup device, or harm to the patient was reported.Following the reported incident, the facility's biomedical engineering department reported being unable to recreate the reported freezing issue.However, they noted that the light source flickers with movement but then is steady.After turning off the dynamic light control setting, a nice picture was obtained with reduced flickering and video lag.

• Brand Name: GLIDESCOPE CORE 15-INCH FHD MONITOR
• Common Device Name: 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: 21304956
• Report Number: 9615393-2025-00017
• Device Sequence Number: 18373312
• Product Code: CCW
• UDI-Device Identifier: 00879123008596
• UDI-Public: (01)00879123008596(11)240108
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/22/2025

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
• Operator of Device: Health Professional
• Device Model Number: 0570-0437
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown