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

Model Number MICBLNDR,W/O HOSES,DOM,H/L

Device Problem Inaccurate Delivery (2339)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported to vyaire medical that the micro blender is not sending out the correct o2 (oxygen) percentage to patients.The customer confirmed that there is no patient harm associated with this reported event.

Manufacturer Narrative

Result of investigation: vyaire failure analysis was duplicate the reported issue.Blender was found to function properly however deliver o2 (oxygen) inaccurately.Depending on gas line conditions, possible contaminants may compromise the function of the micro blender causing the unit to not meet its specified performance.

• 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 ; 8477865998
• MDR Report Key: 18102650
• MDR Text Key: 327759130
• Report Number: 2021710-2023-18383
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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
• Device Operator: Health Professional
• Device Model Number: MICBLNDR,W/O HOSES,DOM,H/L
• Device Catalogue Number: 03800A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/19/2023
• 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