MAUDE Adverse Event Report: VYAIRE MEDICAL BIRD BLENDER; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	03920A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire complaint #: (b)(4).At this time, vyaire has not received the suspect device/component for evaluation.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire that the microblender failed to alarm when one gas was lost.The customer advised there was no patient involvement associated with this event.

• Brand Name: BIRD BLENDER
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9343467
• Report Number: 2021710-2019-11050
• Device Sequence Number: 11319023
• Product Code: BZR
• UDI-Device Identifier: 10846446002355
• UDI-Public: (01)10846446002355(11)20120706
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K973646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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: 03920A
• Device Catalogue Number: 03920A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1