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

Model Number 0570-0366

Device Problem Erratic or Intermittent Display (1182)

Patient Problems Low Oxygen Saturation (2477); Swelling/ Edema (4577)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

A customer reported that during an emergency care procedure, using a glidescope go monitor, the screen went blank 4 times.The physician using the device reported that "2 out of the 4 times i was visualizing cords and ready to place ett and the screen would go blank." it was reported that the patient decompensated as shown by low o2 sats and decreased heart rate.The intubation was completed with assistance from anesthesia.The customer reported that the following day, x-ray showed swelling around the trachea and retropharyngeal free air from placing the ett during the emergent intubation.Follow-up information received from the customer indicated that the patient was extubated a few days later and the retropharyngeal free air resolved on repeat imaging without further complication or need for intervention.

Manufacturer Narrative

The customer's glidescope go monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned glidescope go monitor but was unable to confirm the reported image issue.When connecting the customer's glidescope go monitor to known, good, test verathon equipment and manipulated, the video image was normal.No sign of damage to the hdmi connector was noted by the verathon technical service representative.The camera image quality test was performed and passed.Upon completion of the evaluation, the returned glidescope go monitor was certified and its software was updated to the latest version prior to being returned back to the customer.The customer reported a spectrum single-use blade (exact model unknown) was used in combination with the glidescope go monitor during the reported event but indicated that they had isolated the issue to the monitor.The spectrum single-use blade was disposed of and therefore could not be returned to verathon for evaluation.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: 15021816
• MDR Text Key: 303803680
• Report Number: 9615393-2022-00115
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006189
• UDI-Public: 010087912300618911210315
• 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: 06/17/2022

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: 07/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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