MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GO MONITOR; LARYNGOSCOPE, RIGID

Model Number 0570-0366

Device Problems Power Problem (3010); Intermittent Loss of Power (4016)

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

Event Date 04/25/2023

Event Type  malfunction  

Event Description

A customer reported that during an emergent patient procedure, using a glidescope go monitor, the monitor would repeatedly shut down.The procedure was completed using a different glidescope system which was made available in less than two (2) minutes.No harm to the patient was reported.

Manufacturer Narrative

The reported glidescope go monitor was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned monitor but was unable to confirm the reported power issue.When connected to known, good, test verathon equipment, the monitor functioned as intended.The tsr did not observe an instance of the monitor shutting itself off or losing video signal.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE GO 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: 16987501
• MDR Text Key: 315833762
• Report Number: 9615393-2023-00095
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006189
• UDI-Public: 010087912300618911220816
• 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: 04/25/2023

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: 0570-0366
• Device Catalogue Number: 0570-0368
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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