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

Model Number PT101

Device Problems Use of Device Problem (1670); Protective Measures Problem (3015); Unexpected Shutdown (4019)

Patient Problem Death (1802)

Event Date 03/27/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).The complaint airvo 2 was recently received at fisher & paykel healthcare (f&p) (b)(4) for evaluation to determine the involvement of our product in the reported event.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a patient died whilst using a pt101 airvo2 humidifier.On the date of event, it was reported that the patient had undergone a diaper change at 10.10pm.At 10.30pm, the patient presented hypotension, hypoxia and consciousness disorders and the airvo 2 alarmed and stopped working with error code "e180" displayed.The patient was oxygenated with the ambu bag and diagnosed with hypoxic cardio respiratory arrest.The patient was later intubated and resuscitation was attempted.The patient did not respond to resuscitation and subsequently passed away at 11.30pm.

Event Description

A healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representative that a patient died whilst using a pt101 airvo2 humidifier.On the date of event, it was reported that the patient had undergone a diaper change at 10.10pm.At 10.30pm, the patient presented hypotension, hypoxia and consciousness disorders and the airvo 2 alarmed and stopped working with error code "e180" displayed.The patient was oxygenated with the ambu bag and diagnosed with hypoxic cardio respiratory arrest.The patient was later intubated and resuscitation was attempted.The patient did not respond to resuscitation and subsequently passed away at 11.30pm.

Manufacturer Narrative

(b)(4) method: the complaint airvo 2 humidifier was received at f&p new zealand.The returned device was visually inspected for defects and functionally tested.Our investigation was based upon the information provided by the customer, clinical information of the patient, the functional test of the returned humidifier, and our knowledge of the product.The healthcare facility reported that the patient was admitted into the emergency department for a symptomatology (headache, dry cough without fever) that has been evolving for 1 month.Furthermore, the patient had "respiratory insufficiency", "appearance of dyspnea", "single respiratory failure", "progressive respiratory degradation over a few days".Patient was tested negative for sars-cov2 pcr in nasopharyngeal and enema-brochionlo-alveolar, however ct chest and clinical history suggestive of covid-19 infection with no further diagnosis to confirm.The hospital reported the following sequence of events on (b)(6) 2020.At 4:00pm the patient was set up on airvo 2 humidifier at a flow rate of 55l/min and fio2 of 70%.At 10:10pm the patient's diaper was changed.At 10:30pm the airvo 2 alarmed with the e180 error code.The device was power cycled and when restarted the e180 error code persisted.The patient presented with hypotension, hypoxia and consciousness disorders.Pre-oxygenation with a balloon is administer, intubated and hypoxic cardio respiratory arrest was diagnosed.At 11:30pm, the patient passed away.Results: the unit was functionally tested and continued to operate over an extended period of time with no error codes occurring.Review of the log identified that the e180 error code occurred at approximately 10:11pm and 10:13pm on (b)(6) 2020.The log identified that the airvo 2 humidifier was restarted at approximately 10.13pm which is consistent with the events reported by the hospital.Therapy continued with no further error codes until the patient passed away.The e180 error code can occur when there is a partial blockage of the flow or a rapid increase in the oxygen flow rate to the device.When an e180 alarm is triggered an audible alarm will sound and a visual alarm will display 'fault e180' and 'switch off the unit and then restart'.Conclusion: based on the device analysis, additional information provided by the customer and our knowledge of the product the most likely cause of the airvo 2 humidifier alarming for e180 was due to an unintentional partial blockage of the flow during the diaper change.As part of the investigation the information was assessed and it was determined that the patient's condition was unstable prior to the event with progressive respiratory degradation.The airvo 2 humidifier is designed to provide humidification therapy to spontaneously breathing patients who are not dependent on mechanical respiratory support.The airvo 2 user instruction specifies the following information: do not block the flow of air through the unit and breathing tube.The unit is not intended for life support.Appropriate patient monitoring must be used at all times.Use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption of their oxygen supply.

• 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: 9993859
• MDR Text Key: 188788246
• Report Number: 9611451-2020-00398
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2100779031(11)190523
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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: 2100779031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR