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

Model Number 0570-0376

Device Problems Display or Visual Feedback Problem (1184); Inadequate User Interface (2958)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated, however; at the time of the report the devices have 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.

Event Description

The customer reported that during a patient procedure, using a glidescope core 10-inch monitor, the image froze during intubation.A delay in the procedure of an unspecified duration occurred as another glidescope device was obtained.No harm to the patient or user was reported.

Manufacturer Narrative

The glidescope core 10-inch monitor was returned to verathon for evaluation along with a glidescope quickconnect video baton large.A verathon technical service representative evaluated the returned core 10-inch monitor and was unable to confirm the frozen image failure.A known, good, test quickconnect cable was connected to the customer's quickconnect video baton large and to the customer's core 10-inch monitor.The core monitor was powered on and the video image was normal in both the a and b ports.The core 10-inch monitor was left powered on for several minutes.The camera image quality test was performed and passed.The video image remained normal during testing and certification.The glidescope core 10-inch monitor and glidescope quickconnect video baton large were returned to the customer.No further investigation is 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
• MDR Report Key: 11656052
• MDR Text Key: 249328317
• Report Number: 9615393-2021-00098
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• 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: 04/12/2021
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1