MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM QC MAC S4; LARYNGOSCOPE, RIGID

Model Number	0574-0228
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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the customer's glidescope spectrum qc mac s4 blade nor the glidescope core 10-inch monitor were returned to verathon for evaluation, therefore the cause could not be determined.Furthermore, the customer indicated that they no longer have the blade used at the time of the incident.Follow-up information received from the customer reported that they were unable to replicate the reported issue following the reported event even with the subject blade.Review of complaint history for the reported monitor did not identify any previous complaints reported to verathon.Review of complaint history for the subject blade was unable to be performed due to no lot number being provided.Trending analysis for glidescope spectrum qc blades 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 while using a glidescope core 10-inch monitor during intubation, the clinicians lost the image from the connected glidescope spectrum qc mac s4 blade.The screen was still powered on and the blade was still illuminated.The image was restored after resetting and switching to a new blade.No delay in procedure or harm to the patient was reported.Following the reported incident, the customer reported performing testing and were unable to replicate the fault.The device appeared to be functioning as intended.

• Brand Name: GLIDESCOPE SPECTRUM QC MAC S4
• 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: 23854684
• Report Number: 9615393-2025-00139
• Device Sequence Number: 12019434
• Product Code: CCW
• UDI-Device Identifier: 00879123007957
• UDI-Public: 00879123007957
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: 0574-0228
• Device Catalogue Number: 0270-1086
• Device Lot Number: UNKNOWN
• 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: 11/21/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown