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	Material Separation (1562)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other - the customer did not send physical sample, pictures, or provide a lot number since the sample was disposed.Therefore, no root cause could be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Sample was disposed.
Event or Problem Description
It was reported to vyaire medical that the humidification chamber, 10/cs blew apart (came apart) while on the patient.The patient was on 70lpm (litres per minute) and 80% fio2 (fraction of inspired oxygen).The patient also experienced desaturation but was fine.
Additional Manufacturer Narrative
We performed the dhr (device history record) review, and there was no issue found on lot cm21k30.Since the dhr review reflects that there was no issue during production, we then tried to duplicate the reported issue in our quality control room, and the failure was duplicated.One chamber was placed on the heater base using 2 psi operating pressure (this is the maximum operating pressure mentioned in the ifu), using a mr850 heater base with a temperature of 36 °c to 38 °c.After 6 hours of running time, we blocked the air from coming out of the corrugated tube that connected to the patient's mask.The chamber is still working with no leaks.However, when we input 5 psi of operating pressure and block the tube on the patient end, the leak from the base plate and housing edge happened.The case will become worse when the chamber has been used for a longer time due to the creep of the materials, including the chamber housing.The base plate is made of aluminum, so heat will accumulate over time.When too much pressure forced the housing edge to shift from the base plate.Thus, the shift created a stress that deformed the heated base plate, which caused a water leak.In the worst case, the base plate may separate from the chamber housing.From the study above, we reach the conclusion that the higher operating pressure and the immediate moment of air blocking the patient tube can cause a leak in the chamber.Depending on the operating pressure, the base plate can be blown off the housing.The root cause may come from an air pressure of 5 psi and an immediate moment of air blocking the corrugated tube on the patient side.

• 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; guangdong 44 52 6100; CH 44 526100
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16886910
• Report Number: 3013421741-2023-00032
• Device Sequence Number: 14963327
• Product Code: BZD
• UDI-Device Identifier: 10190752144446
• UDI-Public: (01)10190752144446(10)CM21K30
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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 Expiration Date: 08/29/2023
• Device Model Number: HUMIDIFICATION CHAMBER, 10/CS
• Device Catalogue Number: AH290
• Device Lot Number: CM21K30
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Life Threatening
• Patient Sex: Unknown