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

Model Number 0570-0404

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

The glidescope core 15-inch monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor but was unable to confirm the reported issue.A known good test glidescope quickconnect cable was connected to the monitor port a and port b in succession multiple times without any failures occurring.The video image was normal on all test equipment.The camera image quality test was performed and passed.On completion of the evaluation, the glidescope core 15-inch monitor was returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

Event Description

The customer reported that during a patient procedure, using a glidescope core 15-inch monitor, the image color became saturated and froze.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

• Brand Name: GLIDESCOPE CORE 15" 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: 11624275
• MDR Text Key: 249331096
• Report Number: 9615393-2021-00084
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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