MAUDE Adverse Event Report: VYAIRE MEDICAL INC. MICROBLENDER; MIXER,BREATHING GASES,ANESTHESIA INHALATION

Model Number	MICBLNDR,.15-1.0/2-16 LPM,DISS,CE,LO
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A vyaire representative reported the unit has a leak on the micro-blender component.At this time, there is no information regarding patient involvement associated with the reported event.
Additional Manufacturer Narrative
(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.
Additional Manufacturer Narrative
Vyaire complaint number (b)(4).Overhaul and calibration was performed on (b)(6) 2022 in accordance with the data-recording sheet 91639.The vyaire medical gmbh certified that the equipment serial #(b)(6) had passed all operational specifications and was certified for clinical use.

• Brand Name: MICROBLENDER
• Common Device Name: MIXER,BREATHING GASES,ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• 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: 13372065
• Report Number: 2021710-2022-15353
• Device Sequence Number: 11629422
• Product Code: BZR
• UDI-Device Identifier: 10846446002225
• UDI-Public: (01)10846446002225(11)20111107
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K883038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2022

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
• Operator of Device: Health Professional
• Device Model Number: MICBLNDR,.15-1.0/2-16 LPM,DISS,CE,LO
• Device Catalogue Number: 10040A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 03/29/2022; 06/21/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 05/31/2022; 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2011
• 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