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); Display or Visual Feedback Problem (1184)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

A customer reported that during a patient procedure, using a glidescope core 10-inch monitor, the screen froze several times and then the image went to half-screen causing a delay in patient care.A bflex single-use bronchoscope via glidescope core quickconnect cable and a glidescope spectrum single-use laryngoscope via glidescope core smart cable were being used with the monitor to intubate the patient but the customer reported being unable to isolate the issue to a particular system component.No use of a backup device or harm to the patient was reported.

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.Upon verathon following up with the customer for further troubleshooting, the customer confirmed being unable to isolate the issue to a particular system component but that their biomedical department would do further troubleshooting to make a decision about sending it to verathon for evaluation.To date, no response has been received from the customer indicating they would like to return their system for evaluation.Review of complaint history for the reported monitor serial number "(b)(4)" did not identify any previous complaints reported to verathon.Trending analysis for 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 not required at this time.Verathon will continue to monitor for trends.

• 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: 18607862
• MDR Text Key: 334844853
• Report Number: 9615393-2024-00013
• Device Sequence Number: 1
• Product Code: CCW
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2024

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
• 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: 01/03/2024
• Initial Date FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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