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

Model Number 0570-0404

Device Problems Display or Visual Feedback Problem (1184); No Visual Prompts/Feedback (4021)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope core 15-inch monitor, the image froze five (5) times during a difficult airway management.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

The reported glidescope core 15-inch monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the reported video monitor but was unable to confirm the reported frozen image issue.When connecting the reported video monitor to known, good, test verathon equipment, the image produced on the video monitor was normal.The verathon technical service representatives was unable to confirm the reported frozen image issue when tested with verathon test equipment.The camera image quality test was performed and passed for the reported glidescope core 15-inch monitor.No additional information was provided regarding the verathon glidescope cable and camera used with the glidescope core 15-inch monitor during the reported incident.Upon completion of the evaluation the glidescope core 15-inch monitor was returned back to the customer.At this time no further investigation is required.Verathon will continue to monitor for any ongoing trends.

• 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: 15924621
• MDR Text Key: 308173309
• Report Number: 9615393-2022-00212
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006639
• UDI-Public: 010087912300663911210416
• 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: 11/10/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• 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