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

Model Number PT100

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

Patient Problems Death (1802); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 03/31/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).We are currently in the process of determining if our device have caused or contributed to the reported event.We will provide a follow up report upon completion of investigation.

Event Description

The (b)(4) regulatory authority reported on behalf of a customer that a patient with final stage of chronic obstructive pulmonary disease (copd stage iv) and niv-intolerance died whilst using a pt100 myairvo 2 humidifier.F&p understands that niv-intolerance means that the patient did not tolerate using a noninvasive ventilation (niv) device.The patient had received long-term nasal high flow therapy.It was reported that the patient became somnolent and blood gas analysis was not regularly performed.There was no reported malfunction with the myairvo 2 humidifier, however the hospital enquired if a oxygen flow rate that is too high for a patient is chosen whether this could lead to anaesthesia-like effects in patients.

Event Description

The german regulatory authority reported on behalf of a customer that a patient with final stage of chronic obstructive pulmonary disease (copd stage iv) and niv-intolerance died whilst using a pt100 myairvo 2 humidifier.F&p understands that niv-intolerance means that the patient did not tolerate using a noninvasive ventilation (niv) device.The patient had received long-term nasal high flow therapy.It was reported that the patient became somnolent and blood gas analysis was not regularly performed.There was no reported malfunction with the myairvo 2 humidifier, however the hospital enquired if a oxygen flow rate that is too high for a patient is chosen whether this could lead to anaesthesia-like effects in patients.

Manufacturer Narrative

(b)(4).The complaint device was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of our product.Further information regarding the timeline and care of patient leading up to the patient's passing was provided by the hospital.It was noted that patient had received long-term nasal high flow therapy from when it was prescribed in (b)(6) 2016 until the patient's demise in (b)(6) 2018.Over the two-year period of receiving airvo therapy, the patient had no exacerbations.It was reported that since (b)(6) 2016, blood gas analysis had not been appropriately performed to diagnostically check whether the airvo device was adjusted to the patient's requirements.On the (b)(6) 2018, 7 days before the event date, the patient was admitted due to another clinical event (constipation) unrelated to the incident.Information provided shows that leading up to the patient's demise, blood gas analysis had not been appropriately performed nor were there regular patient monitoring while the patient was on the myairvo therapy at the hospital.On the event date prior to patient's demise, there had been no pulse oximetry on the patient although it was noted that the patient had increasing somnolence and was partially disoriented.Based on the information provided, there is no indication of any malfunction with the complaint device.However, it should be noted that patient monitoring and blood gas analysis were not appropriately performed to ensure suitable blood saturation levels are achieved at the prescribed flow.Long term oxygen therapy (ltot) with nasal high flow (nhf) should be treated the same as ltot with standard nasal prongs.The copd global initiative for chronic obstructive lung disease (gold) guidelines recommends re-evaluating oxygen prescription every 60 to 90 days.During a copd exacerbation the guidelines recommends titrating to a saturation of 88 to 92%.They also recommend doing blood gases regularly to check oxygenation is satisfactory without worsening co2 retention/acidosis.The guidelines and f&p my airvo user instructions state that the therapy setting should be prescribed by the physician i.E.Flow and oxygen saturation range based on patient requirements.The patient should be appropriately monitored and therapy adjusted according to the physician's assessment.The myairvo user instructions contain the following warnings; appropriate patient monitoring must be used at all times.Oxygen flow settings should be titrated accordingly to blood saturation levels.It is important that the physician prescribing your oxygen therapy approvers both the flow and oxygen settings and that you do not adjust these prescribed setting without consulting them.Check that suitable blood saturation levels are achieved at the prescribed flow.Use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption of their oxygen supply.The oxygen concentration delivered to the patient can be affected by changes to the flow setting, oxygen setting, patient interface or if the airpath is obstructed.

• Brand Name: MYAIRVO 2 HUMIDIFIER
• Type of Device: MYAIRVO 2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 9709763
• MDR Text Key: 179404137
• Report Number: 9611451-2020-00145
• Device Sequence Number: 1
• Product Code: BTT
• 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,other
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PT100
• Device Catalogue Number: PT100
• Device Lot Number: 111103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death