MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE VIDEO MONITOR (GVM); LARYNGOSCOPE, RIGID

Model Number 0570-0338

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

A customer reported that during a patient procedure, using a glidescope video monitor (gvm), the picture was dropping out and displayed intermittent streaks.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

The customer's glidescope video monitor (gvm) was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor but was unable to confirm the reported image failure.Visual inspection of the monitor did not identify any damage.When connected to known, good, test verathon equipment, there was no intermittent loss of image observed when manipulating the video cable at the monitor end.The customer's monitor passed verathon's device functionality testing.Due to the age of the monitor's battery (> 2 years old), it was replaced; however, there is no indication that the battery caused or contributed to the reported image issues.Neither the cable nor the laryngoscope used with the monitor during the reported event were made available to verathon for evaluation.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE VIDEO MONITOR (GVM)
• 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: 17921844
• MDR Text Key: 325511084
• Report Number: 9615393-2023-00193
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0338
• Device Catalogue Number: 0570-0338
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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