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	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope core 15-inch fhd monitor was returned to verathon for evaluation along with the glidescope core smart cable used during the reported event.A verathon technical service representative evaluated the returned devices but was unable to confirm the reported failure.Both the monitor and smart cable passed visual inspection.When connecting the customer's monitor to verathon's test equipment, a normal image was produced.The monitor passed verathon's device functionality testing and was confirmed to be within specification.Next, when connecting the customer's smart cable to verathon's test equipment, it also produced a normal image and passed device functionality testing.The laryngoscope used during the reported event was not made available to verathon for evaluation.Upon completion of verathon's device evaluation, both the monitor and the smart cable were returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported while using a glidescope core 15-inch fhd monitor, the screen went blank during intubation.They reported the issue occurred during an emergency care procedure and resulted in an unspecified delay in treatment.No use of a backup device or harm to the patient was reported.
Additional Manufacturer Narrative
G3, g6, h2, h11.Following verathon's initial report submission, a verathon engineering representative visited the facility to further investigate the reported image issues with their glidescope systems.The verathon engineer was unable to replicate the reported image issues.Verathon remains in contact with the facility and continues to investigate the potential cause of the reported image issues.Should additional information become available, a supplemental report will be submitted in accordance with 21 cfr 803.56.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• 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: 20845876
• Report Number: 9615393-2024-00149
• Device Sequence Number: 14395521
• Product Code: CCW
• UDI-Device Identifier: 00879123008596
• UDI-Public: (01)00879123008596(11)240514
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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