MAUDE Adverse Event Report: VYAIRE MEDICAL LOW FLOW MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	LOW FLOW MICROBLENDER 9320
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the 3920 low flow micro blender series fio2 is out of specs.As of this time there is no information about patient involvement in this reported event.

• Brand Name: LOW FLOW MICROBLENDER
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9909035
• Report Number: 2021710-2020-11689
• Device Sequence Number: 3375016
• Product Code: BZR
• UDI-Device Identifier: 10846446002355
• UDI-Public: (01)10846446002355(11)20190508
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K883038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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: LOW FLOW MICROBLENDER 9320
• Device Catalogue Number: 03920A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1