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

Device Problem Gas/Air Leak (2946)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/01/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 330933119
• Report Number: 3013421741-2023-00051
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10190752141643
• UDI-Public: (01)10190752141643(10)TL2301009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HUMIDIFIER KIT 500ML 12/CS
• Device Catalogue Number: 2620
• Device Lot Number: TL2301009
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention