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

Model Number	0570-0404
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope core 15-inch monitor was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device and was able to confirm the reported power issue, failing verathon's device functionality testing.The tsr replaced both the main and coin cell batteries.Based on verathon's device evaluation, the most probable cause of the event is reduced battery capacity due to normal aging of the internal lithium-ion battery.Per device labeling, the monitor battery maintains full charge capacity for approximately 500 charge cycles, after which battery capacity may decrease.The device in this case is approximately six (6) years old, and battery performance degradation over time is consistent with expected lithium-ion battery behavior.The glidescope core operations & maintenance (omm) indicates that users should ensure the battery is sufficiently charged prior to use and verify proper device function through a pre-use functional check.The omm also describes battery status indicators and associated battery life.Additionally, users are advised to ensure alternative airway management equipment is readily available.Upon completion of the device evaluation and repair, the monitor was returned to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported during an intubation, using a glidescope core 15-inch monitor, the display intermittently lost power and went blank, resulting in loss of visualization.No delay in procedure, use of a backup device, or harm to the patient was reported.Following the reported event, the facility's biomedical engineering representative reported the device showed approximately 60-70 minutes of battery life and the unit appeared to function normally when tested.They also reported the monitor's date and time settings reset after powering off, suggesting a possible battery-related issue.

• Brand Name: GLIDESCOPE CORE 15-INCH MONITOR
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C5A 9; CA V5C5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C5A 9; CA V5C5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 24810823
• Report Number: 9615393-2026-00045
• Device Sequence Number: 9943980
• Product Code: CCW
• UDI-Device Identifier: 00879123006639
• UDI-Public: (01)00879123006639(11)200505
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 0570-0404
• Device Catalogue Number: 0270-1033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2020
• 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