MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO2 HUMIDIFIER

Model Number PT101

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Aspiration/Inhalation (1725); Low Oxygen Saturation (2477)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

A hospital in france reported that a patient called the staff because a significant quantity of water was flowing from their cannula which was in use with a pt101 airvo2 humidifier.It was reported that the patient inhaled water, which caused desaturation.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).The airvo is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.The complaint airvo humidifier was not returned to fisher & paykel healthcare (fph) for evaluation but it is still in service at the hospital.Following this complaint we attempted to obtain further information regarding the operating environment and actions taken relative to the patient.When our fph field representative visited the hospital in order to gather more details, he was informed that no further information was available.Additionally he was told that neither the biomedical engineering department nor the head nurse were aware of this event.Conclusion: based on the description of events, it appears likely that condensation had built up in the heated breathing tube and had not been cleared by staff.Condensate in the humidification system, although not preferred, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by multiple setup and environmental factors.Our user instructions that accompany the airvo humidifier state that "if excess condensation accumulates in the heated breathing tube, drain by lifting the patient end of the tube, allowing the condensate to run into the water chamber." in addition we have recently provided guidance for hospitals to assist with condensate management.This guidance is contained in the airvo troubleshooting guide and states the following: - if condensation is present, drain it back into the water chamber.- disconnect the patient interface from the heated breathing tube.- drain the tube by lifting the patient end of the tube, allowing the condensate to run into the water chamber.- at higher target flow rates, it may be necessary to first reduce the target flow rate to 30 l/min or below, to ensure the condensate drains into the water chamber.The airvo 2 user manual instructs the user to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." the user manual also states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." and that "the unit is not intended for life support.".

• Brand Name: AIRVO2 HUMIDIFIER
• Type of Device: AIRVO2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4338937
• MDR Text Key: 5216798
• Report Number: 9611451-2014-00936
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/20/2014

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
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 120715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1