MAUDE Adverse Event Report: VYAIRE MEDICAL P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	LOW FLOW BLENDER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However, the complaint will be treating as and out of box failure (obf) and will replace the blender.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56.If additional information becomes available.
Event or Problem Description
The customer reported to vyaire medical that the low flow microblender ventilator is reading high and out of specification at a dial setting of 21%.Furthermore, there was no patient associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire medical was unable to confirm or duplicate the reported issue as no performance issues were found.The utt (unit under test) was visually inspected and there was no evidence of damage or misuse.Installed utt assembly onto blender station fixture fa-lab gage id: a07012 and applied wall air and oxygen, the fraction of inspired oxygen (fio2) was set to 21% after 20 minutes and the fio2 external reading using servomex analyzer gage id: e00940 read at 22.13 percent.The fio2 was set to 30 %, 60 %, and 90 %, allowing each setting to flow for at least 20 minutes.All readings passed at each check point within the test specification.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
The problem occurred during testing; the unit failed dealer pre-acceptance testing and was never put in clinical use.

• Brand Name: P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13023279
• Report Number: 2021710-2021-15175
• Device Sequence Number: 11194126
• Product Code: BZR
• UDI-Device Identifier: 10846446002355
• UDI-Public: (01)10846446002355(11)20210120
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K883038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2021

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 BLENDER
• Device Catalogue Number: 03920A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 12/17/2021; 04/21/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/23/2022; 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown