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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope core 15-inch monitor was evaluated by a verathon clinical specialist at the customer's facility, but they were unable to confirm the reported image issue.The monitor's software was updated to the latest version by the verathon clinical specialist despite being unable to reproduce the reported issue.The customer reported that they were going to continue using the monitor.To date, no other issues have been reported to verathon.Review of complaint history for the reported monitor serial number " (b)(6) " did not identify any previous complaints reported to verathon.Trending analysis for glidescope core monitors 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.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that while placing a double lumen tube with a glidescope bflex 3.8 single-use bronchoscope during a patient procedure, the screen on the connected glidescope core 15-inch monitor froze momentarily.They reported that the screen froze while placing the tube as soon as they reached the patient's lungs.They reported powering the monitor off and back on which resolved the frozen image issue.No delay in the procedure, use of a backup device, or harm to the patient was reported.

• 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: 20560489
• Report Number: 9615393-2024-00139
• Device Sequence Number: 21054221
• Product Code: CCW
• UDI-Device Identifier: 00879123006639
• UDI-Public: (01)00879123006639(11)220701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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