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

Model Number PT101

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint airvo humidifier is currently en route to fisher & paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported that while a patient was using an airvo 2 humidifier condensate came from the nasal cannula into the patient's nose and he started 'choking'.The hospital confirmed that there was no patient injury.

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 was returned to fisher & paykel healthcare in (b)(6).The airvo was set up with a 900pt501 heated breathing tube, an opt944 cannula and an mr290 chamber and was test run at 35lpm.Results: during testing the returned airvo functioned normally and no error codes were displayed.Some condensate was produced but the amount was only slightly above the average expected amount for this model.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 regularly enough 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.

Event Description

A hospital in (b)(6) reported that while a patient was using an airvo 2 humidifier condensate came from the nasal cannula into the patient's nose and he started 'choking'.The patient was transferred to another airvo and therapy continued with no further incident.The hospital confirmed that there was no patient injury.

• 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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7058218
• MDR Text Key: 93574557
• Report Number: 9611451-2017-01086
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: 0109420012422354
• 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,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2017
• 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: 140303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1