MAUDE Adverse Event Report: VYAIRE MEDICAL M2M ASSY, PKG, REVEL, GRN, DISS, ENGL; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	M2M ASSY, PKG, REVEL, GRN, DISS, ENGL
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that there were complaints of an o2 leak.Biomed indicates they have the o2 connected at 50 psi and turns it off the psi slow decreases.After following up on the issue biomed informed vyaire that the red mounts for the o2 blender had somehow become partially loose on the side away from the blender.This allowed just a very slightly imperfect seal allowing the leak to occur but not affecting o2 outputs in the case testing.Issue has been resolved.No patient involvement was reported.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).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.
Additional Manufacturer Narrative
Investigation findings: the red mounts for the o2 blender had somehow become partially loose on the side away from the blender.This allowed just a very slightly imperfect seal allowing the leak to occur but not affecting o2 outputs in the case testing.Issue has been resolved.

• Brand Name: M2M ASSY, PKG, REVEL, GRN, DISS, ENGL
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• 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 ; 2402760001
• MDR Report Key: 19087266
• Report Number: 2021710-2024-19000
• Device Sequence Number: 7128120
• Product Code: CBK
• UDI-Device Identifier: 00845873000029
• UDI-Public: (01)00845873000029
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070594
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: M2M ASSY, PKG, REVEL, GRN, DISS, ENGL
• Device Catalogue Number: 19260-001
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2013
• 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