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

Model Number 0570-0404

Device Problems No Display/Image (1183); Visual Prompts will not Clear (2281)

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

Event Date 09/15/2020

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 15" monitor, the glidescope monitor went black during intubation.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

D9, g3, g6, h2, h3, h6, h10 the glidescope core 15" monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor and confirmed the reported issue.There was no video image and the monitor would not recognize the test batons used by the service representative.The issue was isolated by the service representative to the main pcba board inside the monitor, which was replaced.The monitor was then returned to the customer on completion of repair.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 15" 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: 10678067
• MDR Text Key: 214812485
• Report Number: 9615393-2020-00200
• 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: 09/15/2020

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: 09/22/2020
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1