MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	HUMIDIFICATION CHAMBER, 10/CS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that water was noted to be dripping from the sealant edge of the airlife¿ autofill humidification chamber where it meets the metal plate.Water was found to be pooled on the floor, surrounding the high flow machine.The electrical heater wire and circuit appeared wet.No alarm.End users felt that as the humidification bag filled with water and expanded, it caused pressure on the humidification chamber.It happened during patient use.Interventions included replacement of the humidification chamber/circuit and immediate removal of the high flow machine for checking of machine and heater wires.No fault of damage to machine or heater wires reported.The patient remained stable.No harm reported.
Additional 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.The issue occurred with four patients.Please see (b)(4), (b)(4), and (b)(4) for the rest.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Additional information: g3, g6, h2, h3, h6 and h10 result of investigation: vyaire medical was not able to verify the reported issue.Vyaire believe that water leakage occurs because the maximum operating pressure is generated in the use process, and the staff will cause the air to reverse pour into the water bag under this pressure, resulting in the expansion of the water bag.However, in this complaint, no further investigation was performed as the product was lost while in transit.Therefore, a definitive root cause could not be determined, and corrective or preventive action is not indicated at this time.

• Brand Name: AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): CHINAMED PRODUCTS (CHINA) LTD.; xin tang industrial park jiao; tang town gaoyao district guan; guangdong 44 52 6100; CH 44 526100
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16770405
• Report Number: 8030673-2023-00314
• Device Sequence Number: 6398262
• Product Code: BZD
• UDI-Device Identifier: 10190752144446
• UDI-Public: (01)10190752144446(10)CM21N20
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: HUMIDIFICATION CHAMBER, 10/CS
• Device Catalogue Number: AH290
• Device Lot Number: CM21N20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown