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 Mechanical Problem (1384)

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

Event Date 09/17/2021

Event Type  malfunction  

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.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

Event Description

The customer reported to vyaire medical blender is reading high and out of spec at a dial setting of 21%.The reporter confirmed that there is no patient involvement associated on this event.

Manufacturer Narrative

Result of investigation:the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The reported issue was not reproducible and no performance issues were found.A visual inspection of blender did not show signs of physical damage.The fio2 (fraction of inspired oxygen) was changed to 30%, 60%, 90% and 100% while allowing it to flow at each setting for a minimum of 20 minutes.All readings at each set point were within 2% of set value which are within the +/- 3% specification.

• Brand Name: P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
• Type of Device: 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: 13023350
• MDR Text Key: 282389494
• Report Number: 2021710-2021-15168
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 10846446002355
• UDI-Public: (01)10846446002355(11)20210120
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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: 03920A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• 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