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

Model Number	0570-0404
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope core 15-inch monitor, there were purple, pink, and blue lines on the screen and the image was breaking up.No delay in the procedure, use of a backup device, or harm to the patient was reported.This incident occurred with a loaner monitor provided by verathon while the customer's monitor was being serviced at verathon for a similar reported issue.
Additional Manufacturer Narrative
The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.Verathon is conducting a voluntary correction for a limited number glidescope core 15 and core 15 fhd monitors.Verathon has received 12 complaints from customers about a loss of image when using a core 15 or core 15 fhd monitor in conjunction with unique combinations of the glidescope core 2m quickconnect cable (0600-0843) and spectrum qc single-use video laryngoscopes.No injuries have been reported.Verathon has implemented a correction in the form of a software update (core 15: v1.10 and core 15 fhd: v1.8) to prevent a loss of image.Verathon's investigation confirmed that with these unique combinations that a video signal delay issue can contribute to a degradation in image quality, a loss of image, or the airway cannot be visualized.This may lead to a delay in the procedure until a replacement or alternative device is obtained, which may cause serious injury.
Additional Manufacturer Narrative
The subject glidescope core 15-inch monitor used during the reported incident was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor but was unable to confirm the reported image issues.When connected to verathon's known, good, test equipment, no discoloration, blinking, or lines were observed.The monitor was tested with several titanium reusable blades, spectrum single-use blades, a quickconnect video baton, and a bflex single-use bronchoscope.Both ports a and b were tested with each blade and baton at the same time and separately.No image issues were observed and the monitor was working as intended.The glidescope core 15-inch monitor passed verathon's device functionality testing.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 15-INCH 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: 19326323
• Report Number: 9615393-2024-00076
• Device Sequence Number: 19484900
• Product Code: CCW
• UDI-Device Identifier: 00879123006639
• UDI-Public: 010087912300663911200602
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Recall,Modification/Adjustment,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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: 0570-0404
• Device Catalogue Number: 0270-1033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2021-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown