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

Model Number 0570-0366

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

The customer reported that during an emergency care patient procedure, using a glidescope go monitor, the image intermittently "blacks out" when the hdmi connection on the monitor was manipulated.The procedure was completed using a backup device, which was made available in an unspecified amount of time.No harm to the patient was reported.

Manufacturer Narrative

The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

The reported glidescope go monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the reported video monitor but was unable to confirm the customer's initial reported image issue.When connecting the reported video monitor to known, good, test verathon equipment, the image produced on the video monitor was normal.The verathon technical service representatives was unable to confirm the reported intermittent image issue.The camera image quality test was performed and passed for the reported glidescope go monitor.The verathon technical service representative next performed a visual inspection for the reported video monitor and reported finding damage to the monitor's power button, which was unable to be repaired.Upon completion of the evaluation the reported glidescope go monitor was scrapped due to the damage found to the power button only, and the customer was provided a new replacement glidescope go monitor for their facility.At this time no further investigation is required.Verathon will continue to monitor for any ongoing 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: 15625809
• MDR Text Key: 307190130
• Report Number: 9615393-2022-00171
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006189
• UDI-Public: 010087912300618911201210
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• 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