MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE AVL VIDEO BATON 3-4; LARYNGOSCOPE, RIGID

Model Number	0570-0313
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glidescope avl video baton 3-4 was returned to verathon for evaluation.A verathon technical service representative evaluated the returned video baton.A visual inspection of the baton was performed and no abnormalities were discovered.The image produced by the video baton was good; the baton functioned as expected.The baton was returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
The customer reported that during an emergency care procedure, using a glidescope avl video baton 3-4, the avl monitor was not showing an image.This only occurred with the reported baton and there was no visible damage to the baton.A delay in the procedure of approximately one (1) hour occurred while a back-up avl baton was obtained.No harm to the patient or user was reported.

• Brand Name: GLIDESCOPE AVL VIDEO BATON 3-4
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 9730196
• Report Number: 9615393-2020-00028
• Device Sequence Number: 418648
• Product Code: CCW
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: 0570-0313
• Device Catalogue Number: 0570-0313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1