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

Model Number 0570-0404

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2021

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope core 15-inch monitor, the image was yellow and was "not operable".Afterwards, when the biomed attempted to inspect the monitor it was observed the monitor would "not respond".They attempted to restart the monitor but it would not turn off, and had an hourglass that stayed on the monitor screen.No delay in the procedure, use of a backup device, or harm to the patient or user 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

A replacement glidescope core 15-inch monitor was provided to the customer and the customer's glidescope core 15-inch monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor and was unable to confirm the reported issues.The verathon technical services representative observed the image was normal with or without a known, good, test camera and test cable connected.When evaluating the reported power management issue, the verathon technical service representative observed the battery was at 0% upon arrival, when connecting power to the monitor the led indicator light illuminated as normal.After ten (10) minutes of charging, the battery level increased to 4% with the charging symbol appearing on screen right next to the battery icon.The camera image quality test was performed and passed.Upon completion of the evaluation, the glidescope core 15-inch monitor was scrapped as the customer had already received a replacement glidescope core 15-inch monitor.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 15-INCH 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: 12780717
• MDR Text Key: 281395968
• Report Number: 9615393-2021-00334
• 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 Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

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: 0570-0404
• Device Catalogue Number: 0270-1033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 11/16/2021
• Supplement Dates FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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