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

Model Number HUMIDIFICATION CHAMBER, 10/CS

Device Problem Material Separation (1562)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/10/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 314751941
• Report Number: 3013421741-2023-00032
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10190752144446
• UDI-Public: (01)10190752144446(10)CM21K30
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening