MAUDE Adverse Event Report: VYAIRE MEDICAL INC AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number	HUMIDIFIER KIT 500ML 12/CS
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported to vyaire medical that 2620 humidifier kit 500ml 12/cs is producing 0 air sound from the cannula even when it is on 4 liters during patient use.The patients saturation dipped below 60.The nurse disconnected the oxygen tubing from the humidifier and replaced the humidifier with a new one and the patients saturation increased to 78.They were able to wean 02 back down to 2l.They observed a large crack in the plastic where oxygen must have been leaking out.Furthermore, there was no harm on the patient.

• Brand Name: AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18360734
• Report Number: 3013421741-2023-00051
• Device Sequence Number: 12766053
• Product Code: BTT
• UDI-Device Identifier: 10190752141643
• UDI-Public: (01)10190752141643(10)TL2301009
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K853146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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: HUMIDIFIER KIT 500ML 12/CS
• Device Catalogue Number: 2620
• Device Lot Number: TL2301009
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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