MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 10-INCH MONITOR; LARYNGOSCOPE, RIGID

Model Number 0570-0376

Device Problems Intermittent Continuity (1121); Display or Visual Feedback Problem (1184)

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

Event Date 01/14/2022

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope core 10-inch monitor, the image would intermittently freeze.The customer stated they turned the monitor off and then on again, but the image continued to freeze.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

The device has been received, however; at the time of the report the device has not been evaluated 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 core 10-inch monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor but was unable to confirm the initial reported freezing issue.The verathon technical service representative did observe that when powering on the monitor the monitor icons failed to produce intermittently.To address the reported issue found the verathon technical service representative reloaded the software on the glidescope core 10-inch monitor.Over the next several days the verathon technical service representative repeated the following troubleshooting steps to confirm the found issue did not occur again: they charged the monitor overnight, disconnected the monitor from power, powered the monitor back on, confirmed touch screen was working and verified the monitor icons were present on the screen.No further issues found after performing initial software reload to the monitor.Upon completion of the evaluation the glidescope core 10-inch monitor was returned back to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 10-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: 13480982
• MDR Text Key: 287902676
• Report Number: 9615393-2022-00021
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006509
• UDI-Public: 010087912300650911191014
• 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: 01/14/2022

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: 0570-0376
• Device Catalogue Number: 0270-0996
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 02/21/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2019
• 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