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

Model Number 0570-0376

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

The customer declined the option to have their glidescope core 10-inch monitor returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Follow-up communication received from the customer indicated that they performed troubleshooting at their facility and reported that the system was working fine.No information was provided regarding the customer's resolution or the cable and/or laryngoscope used with the monitor during the reported event.Review of complaint history for the reported serial number " (b)(6)" did not identify any previous complaints reported to verathon.Trending analysis for the glidescope core monitors 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.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.

Event Description

A customer reported that during a patient procedure, using a glidescope core 10-inch monitor, the screen was freezing.No delay during the procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDESCOPE CORE 10-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: 17347298
• MDR Text Key: 319589627
• Report Number: 9615393-2023-00137
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006509
• UDI-Public: 010087912300650911201208
• 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: 06/29/2023

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: 0570-0376
• Device Catalogue Number: 0270-0996
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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