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

Device Problem Obstruction of Flow (2423)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/12/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 330932794
• Report Number: 8030673-2023-00367
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10190752114791
• UDI-Public: (01)10190752114791(10)0004239910
• Combination Product (y/n): N
• PMA/PMN Number: K991484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• 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 EMPTY 6 PSI BLUE CAP 50/CS
• Device Catalogue Number: 2006
• Device Lot Number: 0004239910
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male