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

Model Number MICROBLENDER

Device Problem Mechanical Problem (1384)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/20/2022

Event Type  Death  

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 becomes available.

Event Description

It was reported to vyaire medical that the microblender was incorrectly set to 21% fio2 (fraction of inspired oxygen).The patient was in critical desaturation while using the optiflow thrive.The patient has expired.

• 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: 14812456
• MDR Text Key: 294755254
• Report Number: 2021710-2022-16346
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 10846446002348
• UDI-Public: (01)10846446002348
• 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
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 03800A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Death