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

Model Number AIRLIFE¿ BUBBLE HUMIDIFIER WITH 6 PSI PRESSURE RELIEF VALVE

Device Problem Defective Device (2588)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has 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

The customer reported that the airlife¿ bubble humidifier with 6 psi pressure relief valve experienced flow issue that resulted to patient desaturation.As an intervention, both cannula and bottle were changed.

Manufacturer Narrative

Result of investigation: picture and samples received for investigation without lot numbers.The samples were visually inspected.However, no issues were found.Therefore the defect reported by the customer was not confirmed.

• Brand Name: AIRLIFE¿ BUBBLE HUMIDIFIER WITH 6 PSI PRESSURE RELIEF VALVE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• MDR Report Key: 11766705
• MDR Text Key: 248762147
• Report Number: 8030673-2021-00161
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10190752114791
• UDI-Public: (01)10190752114791(10)0004166020
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

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
• Device Operator: Health Professional
• Device Model Number: AIRLIFE¿ BUBBLE HUMIDIFIER WITH 6 PSI PRESSURE RELIEF VALVE
• Device Catalogue Number: A5U580A4
• Device Lot Number: 0004166020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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