MAUDE Adverse Event Report: VYAIRE MEDICAL MICBLNDR,1.0-10.0/2-16 LPM,DISS,CE,LO; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	MICBLNDR,1.0-10.0/2-16 LPM,DISS,CE,LO
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that a loud leak on both sides of the lower housing was noted while on a patient.No patient harm was reported.
Additional Manufacturer Narrative
Vyaire medical file indentification: (b)(4).H3: 81-- h3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: MICBLNDR,1.0-10.0/2-16 LPM,DISS,CE,LO
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north 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: 18966254
• Report Number: 2021710-2024-18918
• Device Sequence Number: 7050698
• Product Code: BZR
• UDI-Device Identifier: 10846446002157
• UDI-Public: (01)10846446002157
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MICBLNDR,1.0-10.0/2-16 LPM,DISS,CE,LO
• Device Catalogue Number: 10042A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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