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

Model Number LOW FLOW BLENDER

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  malfunction  

Event Description

It was reported to vyaire medical that fraction of inspired oxygen inaccuracy occurred on the microblender device.When set at 21% and 100% it is reading 25% and 97%.The customer reported there was no patient involvement associated with the reported event.

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.

Manufacturer Narrative

Results of investigation: vyaire medical received the device for evaluation.A visual inspection of assembly was performed and found no indications of damage, misuse, or contamination.Blender was installed onto test station and testing was performed according to test standards.A calibrated o2 analyzer was used to measure o2 accuracy.With blender set at 60% and flow meter at 2lpm, analyzer measured 58.3% (spec 60 ±3%).Proceeded to test blende.Found blender to be delivering within specification at all set points, through both primary and auxiliary outlets.21% end point was measured on analyzer to be at 22.0% (spec 20.9-22.9%) and 100% end point measured at 99.1%.The reported complaint was unable to be duplicated.Service records indicate this blender underwent a 2-year preventive maintenance overhaul on 01nov2023, passing on all counts.The reported complaint was unable to be reproduced.Blender assembly was tested in accordance with instruction manual and test standard procedures and was found to be performing to specifications.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 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 ; 2402760001
• MDR Report Key: 18223265
• MDR Text Key: 329570639
• Report Number: 2021710-2023-18438
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 10846446002195
• UDI-Public: (01)10846446002195
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LOW FLOW BLENDER
• Device Catalogue Number: 10041A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1