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

Model Number 0570-0304

Device Problems Erratic or Intermittent Display (1182); Poor Quality Image (1408)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated; however, at the time of the report the device has not been received by verathon.

Event Description

The customer reported that during a patient procedure, using a glidescope avl monitor, the image was cutting in and out.The issue was isolated to the monitor.A delay of an unknown duration occurred as another glidescope was obtained.No harm to the patient or user was reported.

Manufacturer Narrative

The glidescope avl monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned glidescope avl monitor and the "no image" issue could not be reproduced.The unit functioned as intended.The technical service representative noted that the front button panel was peeling and the back shell was cracked.The front and back shells were replaced and the glidescope avl monitor was returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE AVL 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: 10070756
• MDR Text Key: 191810635
• Report Number: 9615393-2020-00107
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0304
• Device Catalogue Number: 0570-0314
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1