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

Model Number	0570-0437
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope core 15-inch fhd monitor was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device but was unable to replicate the reported issue.Visual inspection did not identify any physical damage.The tsr charged the monitor to 82 minutes and operated for 30 minutes without experiencing premature shut down.The device passed verathon's device functionality testing and confirmed to be within specification.The monitor contains an internal lithium-ion battery.Per device labeling, battery capacity may decrease over time and with repeated charge/discharge cycles.The glidescope core operations & maintenance manual (omm) instructs users to verify sufficient battery charge prior to use and perform a functional check before clinical use.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 verathon's device evaluation, the monitor was returned to the customer.No further investigation is required at this time.Verathon will continue to monitor trends.
Event or Problem Description
A customer reported that while using a glidescope core 15-inch fhd monitor, the device unexpectedly shut down during a patient procedure.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 was unable to reproduce the reported issue and indicated that the battery was maintaining a charge of approximately 81 to 82 minutes.

• 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 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: 24810825
• Report Number: 9615393-2026-00047
• Device Sequence Number: 9944477
• Product Code: CCW
• UDI-Device Identifier: 00879123008596
• UDI-Public: (01)00879123008596(11)240410
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 0570-0437
• Device Catalogue Number: 0270-1033-FHD
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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