MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Low Oxygen Saturation (2477)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested from the hospital as part of the root cause analysis.The customer provided additional information regarding the patient's medical history relevant to this event: the clinical history of the patient related to the hospital admission included "interstitial lung disease leading to the discontinuation of cordarone responsible for chronic respiratory failure" along with other cardiovascular issues such as high blood pressure, peripheral arterial disease, ischemic heart disease with a history of double bypass and angioplasty, pulmonary hypertension, left ventricular hypertrophy, and second degree atrioventricular block.It was reported by the hospital that the airvo 2 humidifier was functioning, with no power losses during the time of the incident.The hospital stated that the oxygen was hard to regulate, as interpreted by the 90ix170 flowmeter.Method: the complaint pt101 airvo 2 humidifier was received at fisher & paykel healthcare (b)(4) for investigation.The unit was visually inspected for defects and functionally tested for an extended period.The precision medical flowmeter was received at our fisher & paykel healthcare (f&p) service center in france and was visually inspected.Results: during testing, the airvo 2 humidifier powered on and was found to be fully functioning.There was no fault found with the device.Visual inspection of the returned precision medical flowmeter did not reveal any physical damages.The flowmeter was connected to an oxygen supply at f&p service centre and did not reveal any faults however, this is not a f&p manufactured device so notification to the manufacturer precision medical has been sent.Conclusion: based on the device analysis, our knowledge of the product, and additional information provided by the customer, our investigation has confirmed that the airvo 2 humidifier was functioning as designed and there was no malfunction.The reporter indicated that there was no flow, when they referred to the precision medical 90ix170 flowmeter.This may indicate that there was no flow or an interruption to the flow to the flowmeter itself.The oxygen supply and flowmeter are not part of the airvo 2 humidifier.The duration of use at default oxygen setting on the patient of 21% is unknown.The patient had demonstrated signs of desaturation prior to the set-up and may have been dependent on the oxygen supply.This report was submitted to fda as a discretionary measure.Our investigation found no evidence that the airvo 2 humidifier, a f&p manufactured device, caused or contributed to the unanticipated serious injury, as reported by the customer.The pt101 airvo 2 humidifier user manual 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 "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." additionally, the user manual also warns the user: the unit is not intended for life support.Appropriate patient monitoring must be used at all times.Loss of therapy will occur if power is lost.

Event Description

A healthcare facility in (b)(6)reported that a patient experienced significant desaturation and at 1200 hours, saturation levels were at 60%.The patient was setup on a pt101 airvo 2 humidifier at the time of the event.It was also reported that the "team failed to wind up the fio2 with the thumb wheel" on the precision medical 90ix170 flowmeter.The flow settings on the airvo humidifier were set at 40lpm and 37 c with the fio2 initially at 63% and then 21%.Additional information was received from the customer on the 25th of february 2020 stating that the patient's condition prior to set-up was "in a desaturation state".The patient was continuously monitored with a pulse oximeter.As a result of the desaturation, the patient went into a resuscitation service.The patient's current condition is now deceased.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 9931434
• MDR Text Key: 187861712
• Report Number: 9611451-2020-00255
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2100543173(11)180730
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100543173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Date Manufacturer Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 83 YR