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

Model Number PT101

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Aspiration/Inhalation (1725)

Event Date 02/08/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that condensation formed in a 900pt501 heated breathing tube used with an airvo humidifier.The hospital further reported that when they were examining the patient circuit for water the patient started coughing and water spurted out of the interface, down the patient's nose and face.The hospital stated they felt that the patient had aspirated some fluid.No further patient consequence was reported with regard to this incident.The hospital had the subject airvo checked by the medical physics and no issue was found with its performance.The patient continued using a replacement airvo for high flow oxygen therapy.

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.Method: the complaint airvo humidifier, 900pt501 heated breathing tube and mr290 autofeed humidification chamber was returned to fisher & paykel healthcare in (b)(4).The devices were set up with an opt844 cannula and were test run for six hours, using the customer settings.Results: during testing of the returned airvo and accessories the devices functioned normally and no error codes were displayed.Some beading of condensate was noticed on the tubing wall but there was not an excessive amount of condensation produced.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.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." fph clinical representatives have been working with the hospital to provide ongoing education on condensate management.

• 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: 4592303
• MDR Text Key: 5486156
• Report Number: 9611451-2015-00127
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/10/2015

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: 140224000778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2014
• 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
• Treatment: FISHER & PAYKEL OPT844 NASAL CANNULA; FISHER & PAYKEL 900PT501 ADULT TUBE & CHAMBER KIT