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

Model Number PT101

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problems Pneumonia (2011); Viral Infection (2248); Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information and the subject pt101 airvo 2 humidifier for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

On (b)(6) 2021, a distributor reported on behalf of a healthcare facility in (b)(6), via fisher & paykel healthcare (f&p) field representative, that a pt101 airvo 2 humidifier had displayed an e1 error code.On (b)(6) 2022, it was further reported that the event occurred whilst on an intubated, covid-19 patient and that staff then provided alternative oxygen therapy via a reservoir mask and the patient desaturated to 50% spo2.The patient was then provided with continuous positive airway pressure (cpap) therapy and was re-intubated whilst the subject pt101 airvo 2 humidifier was replaced.The patient died on (b)(6) 2021 and it was reported that the medical cause of death was covid-19 viral pneumonia.We are in the process of requesting further information regarding the reported event.

Manufacturer Narrative

(b)(6).We have reviewed the reported event and the healthcare facility clarified that the patient was stable when the e1 error code was generated, with no further reported patient consequence during the use of airvo 2.Furthermore, the patient was not using any f&p products prior to the patient deterioration, intubation or the death and that the medical cause of death was covid-19 viral pneumonia.As such, we have established that there is no causal relationship between the reported patient consequences and the subject airvo 2, thus the reported event is not considered reportable.However, for completeness, please find below the results of our investigation related to the reported e1 error code.Method: the subject pt101 airvo 2 humidifier (airvo 2) was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected, performance tested and evaluated.Further information was retrieved from the healthcare facility.Our investigation is based on the evaluation of the airvo 2 device, an assessment of the information provided by the healthcare facility and our knowledge of our product.Results: visual inspection of the subject airvo 2 revealed no signs of external or impact damage and it was noted that the filter was missing from the device.Power was applied to the device and it displayed an e1 error code and produced an audible alarm.A review of the device log revealed that on the day of the reported event an e1 error code was generated.An e1 error code may occur due to multiple factors including if the airvo 2 unit was dropped, shaken or exposed to water over time.When an e1 error code is triggered, an audible alarm will sound and a visual alarm will display 'fault e1', 'switch off the unit and then restart'.The subject device was opened for further investigation revealing dust and signs of water ingress including the blower having rusted bearings.Furthermore, the healthcare facility confirmed that the patient was not using any f&p products prior to the patient deterioration, intubation or the death and that the medical cause of death was covid-19 viral pneumonia.Conclusion: based on the investigation findings and our knowledge of the product, the e1 error code likely occurred due to water ingress.It should be noted that there was no reported patient harm when the subject airvo 2 displayed the e1 error code, and the healthcare facility confirmed that the device did not cause or contribute to the reported patient deterioration, intubation, and death.The airvo 2 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 included the following warnings and instructions: 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.Do not store or use the unit where it can fall or be pulled into water.If water has entered the unit enclosure, disconnect the power cord and discontinue use.Never operate the unit if: it has been dropped or damaged, it has a damaged power cord or plug, it has been dropped into water.

Event Description

A distributor reported on behalf of a healthcare facility in turkey, via fisher & paykel healthcare (f&p) field representative, that on (b)(6) 2021, a pt101 airvo 2 humidifier (airvo 2) had displayed an e1 error code.It was further reported that the device generated the e1 error code whilst on a stable covid-19 patient with 92% spo2.The healthcare facility reported that the patient was provided with alternative oxygen therapy whilst the subject airvo 2 was replaced with another airvo 2.The healthcare facility reported that on (b)(6) 2021, the patient was moved from the airvo 2 device and was provided with alternative oxygen therapy as the patient's spo2 values remained stable.On (b)(6) 2021, the patient's condition deteriorated, and the patient was intubated.The healthcare facility further reported the patient deceased on (b)(6) 2021.The healthcare facility confirmed that the patient was not using any f&p products prior to the intubation or the death and that the medical cause of death was covid-19 viral pneumonia.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13286061
• MDR Text Key: 284962560
• Report Number: 9611451-2022-00036
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422309
• UDI-Public: (01)09420012422309(10)2101435012(11)201214
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2101435012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2020
• 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
• Treatment: F&P 900PT405 AIRVO POLE MOUNTING TRAY; F&P 900PT405 AIRVO POLE MOUNTING TRAY; F&P 900PT421 MOBILE POLE STAND; F&P 900PT421 MOBILE POLE STAND
• Patient Outcome(s): Other
• Patient Sex: Male