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

Model Number 0570-0404

Device Problem No Visual Prompts/Feedback (4021)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

The customer stated the "issue had been resolved," and declined the option to have their glidescope core 15-inch monitor returned to verathon for evaluation.The customer did not provide the solution that resolved the issue, just that the initial reported issue had stopped.Since the reported device was not returned to verathon for evaluation, the cause could not be determined.Review of complaint history for the reported glidescope core 15-inch monitor serial number "cn203168" did not identify any previous complaints reported to verathon.Trending analysis for the glidescope core 15-inch monitor does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.

Event Description

The customer reported that during a patient procedure, using a glidescope core 15-inch monitor, the image would freeze requiring the end user to reboot the video monitor.No reported use of a backup device or harm to the patient was reported.

• Brand Name: GLIDESCOPE CORE 15-INCH MONITOR
• Type of Device: 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: 16325670
• MDR Text Key: 309155042
• Report Number: 9615393-2023-00023
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006639
• UDI-Public: 010087912300663911201124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 0570-0404
• Device Catalogue Number: 0270-1033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1