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

Model Number	AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER
Medical Device Problem Codes	Leak/Splash (1354); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that there was a substantial amount of water leaking on the floor from two identical (lot/batch) humidification chamber, 10/cs units.The humidity chamber alarmed when the temperature exceeded 40 degrees celsius.The movement on the metal plate where the chamber plastic is attached felt softer than anticipated.The problem happened with the use of two distinct patients more than two days apart.
Additional Manufacturer Narrative
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
Device evaluation: g3, g6, h2, h3, h6 and h10.Result of investigation: device history record review there is no issue found on lot cm21n20.Since the dhr review reflects that no issue during production.We then try to duplicate the reported issue in our qc room.One chamber was placed on the heater base using 2psi operating pressure (this is the maximum operating pressure mentioned in the ifu), using mr850 heater base with a temperature of 36 ~38 °c, after 6 hours running time, we blocked the air from coming out the corrugated tube that connecting to the patient mask, the chamber is still working with no leak.The root cause may come from air pressure =5psi with an immediate moment of air blocked to 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; 510 technology dr; irvine CA 92618
• 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: 16583769
• Report Number: 3015973929-2023-00001
• Device Sequence Number: 5015093
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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: AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/28/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown