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

Model Number	MICBLNDR,W/O HOSES,DOM,LO
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text: device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the micblndr has an issue with fio2 (fraction of inspired oxygen) being inaccurate.Customer did not specify how inaccurate or at what set points.Furthermore, there was no information regarding patient associated with this event.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h3, h6 and h10.Results of investigation: vyaire medical was able to verify the reported issue.The suspect device was returned for investigation.Vyaire medical received micro blender assy p/n 03800a s/n (b)(6).A visual inspection was performed and found scuffing on body from normal usage, also found knob pointer was loose, did not move accurately when knob was turned.No other indications of damage, misuse or contamination were found.Blender was installed onto test fixture and functional test was performed according to test standard.Blending accuracy was found to be slightly out of specifications at test 6.3 step 4, 30% graduation.Accuracy was measured with a calibrated external o2 analyzer.Blender was also found to fail at 30% check sec.6.4 step 8.The reported complaint was duplicated.Blender was tested according to test standards and was found to be delivering out of specification at 30 and 90% set points.Vyaire records show this unit was last overhauled and tested by factory service on 05-aug-2014, passing on all counts.Blender is overdue for 2yr preventive maintenance overhaul.

• Brand Name: P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 18026382
• Report Number: 2021710-2023-18326
• Device Sequence Number: 15357454
• Product Code: BZR
• UDI-Device Identifier: 10846446002355
• UDI-Public: (01)10846446002355
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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: MICBLNDR,W/O HOSES,DOM,LO
• Device Catalogue Number: 03920A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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