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	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification:(b)(4).H3: 81 other ¿ at this time, the suspect device is not available for evaluation.Therefore, root cause has not been determined yet.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.H3 other text : the device is not available.
Event or Problem Description
It was reported to vyaire medical that the 002006 humidifier empty 6 psi blue cap 50/cs was incorrectly connected to the heater of a ventilator.At this time, there is no information regarding patient involvement associated with the reported event.

• 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: 18428419
• Report Number: 8030673-2024-00368
• Device Sequence Number: 7771619
• Product Code: BTT
• UDI-Device Identifier: 10190752114791
• UDI-Public: (01)10190752114791(10)Q2211210
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: Q2211210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 01/02/2024
• 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
• Patient Sex: Unknown