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

Model Number 0570-0404

Device Problem No Display/Image (1183)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

The customer declined the option to have their glidescope core 15-inch monitor returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Despite multiple follow-up attempts made by verathon, no response has been received from the customer regarding potential troubleshooting or if the issue was isolated to a particular system component.No information was provided regarding the cable or video laryngoscope used with the monitor during the reported event.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.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.

Event Description

A customer reported that during an emergency care procedure, using a glidescope core 15-inch monitor, the hdmi port was not working and no picture was displayed on the screen which caused a delay in treatment during intubation of a patient.The procedure was completed using a portable glidescope system which was made available in an unspecified amount of time.No harm to the patient was reported.

• 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: 18393129
• MDR Text Key: 331724810
• Report Number: 9615393-2023-00230
• 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: 12/01/2023

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: 0570-0404
• Device Catalogue Number: 0270-1033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• 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