MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 10-INCH FHD MONITOR; LARYNGOSCOPE, RIGID

Model Number	0570-0436
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	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope core 10-inch fhd monitor was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned monitor and was able to confirm the reported image issue.When connected to verathon's test equipment, the screen was flickering and intermittently flashing to black.Visual inspection found a damaged connector on the embedded display port (edp) printed circuit board assembly (pcba) which was replaced.In addition, the display assembly was replaced which the monitor then functioned as intended.The customer's monitor failed verathon's device functionality testing and visual inspection.Upon completion of verathon's evaluation, the repaired monitor was returned to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during intubation of a patient, using a glidescope core 10-inch fhd monitor, the screen was flickering and turned black intermittently.The procedure was completed by using the same monitor but they reported jiggling the cable until a clear picture was observed.No delay in the procedure, use of a backup device, or harm to the patient was reported.Following the reported event, the customer's verathon territory manager evaluated the system at the facility and isolated the issue to the monitor.

• Brand Name: GLIDESCOPE CORE 10-INCH FHD 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: 20292115
• Report Number: 9615393-2024-00123
• Device Sequence Number: 17963069
• Product Code: CCW
• UDI-Device Identifier: 00879123008589
• UDI-Public: (01)00879123008589(11)230206
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/05/2024

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: 0570-0436
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown