MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE¿ BUBBLE HUMIDIFIER WITH 6 PSI PRESSURE RELIEF VALVE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number	HUMIDIFIER EMPTY 6 PSI BLUE CAP 50/CS
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that after attempting to place a patient on an intermediate flow nasal cannula (12 lpm).The patient desaturated to 77% spo2.It was discovered that the 002006 humidifier empty 6 psi blue cap 50/cs had no hole present on the 02 flow outlet.The respiratory therapist then placed the patient on hfnc (high flow nasal cannula) at 50% 02.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
Additional Manufacturer Narrative
At this time, the suspect device is not available for evaluation, however, we request a device history record review.The 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.

• Brand Name: AIRLIFE¿ BUBBLE HUMIDIFIER WITH 6 PSI PRESSURE RELIEF VALVE
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18360566
• Report Number: 8030673-2023-00367
• Device Sequence Number: 15432007
• Product Code: BTT
• UDI-Device Identifier: 10190752114791
• UDI-Public: (01)10190752114791(10)0004239910
• Combination Product (Y/N): N
• PMA/510(K) Number: K991484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• 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 EMPTY 6 PSI BLUE CAP 50/CS
• Device Catalogue Number: 2006
• Device Lot Number: 0004239910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male