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

Model Number PT101

Device Problems Loss of Power (1475); Unexpected Shutdown (4019)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(4).We are currently in the process of determining the involvement of our product in the reported event.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in the (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, an event while using a pt101 airvo 2 humidifier 6 months ago.It was reported that there was a power cut and the patient almost passed away.The patient was a palliative patient in the children's ward.The patient required bagging.Subsequently, the patient was moved to the resus unit.It was also stated that the patient later demised.Following the report of the incident, a fisher & paykel healthcare (f&p) field representative in the (b)(6) contacted the healthcare facility to obtain further information about the reported event.We have also contacted the facility via email for further details.We are still awaiting further information.Based on the information provided, there is no indication that there is a correlation between the f&p product and the patient's death.

Event Description

A healthcare facility in the united kingdom reported, via a fisher & paykel healthcare (f&p) field representative, an event that occurred while using a pt101 airvo 2 humidifier 6 months ago.It was reported that there was a power cut and the patient almost passed away.The patient was a palliative patient in the children's ward.The patient required bagging.Subsequently, the patient was moved to the resus unit.It was also stated that the patient later demised.Following the report of the incident, a fisher & paykel healthcare (f&p) field representative in the uk contacted the healthcare facility to obtain further information about the reported event.We have also contacted the facility via email for further details.However, there was no response received from the facility.Based on the information provided, there is no indication that there is a correlation between the f&p product and the patient's death.

Manufacturer Narrative

(b)(4) the complaint device was not returned to fisher & paykel healthcare (f&p) for evaluation.Further information about the reported event including the complaint device and the patient care were requested from the healthcare facility.However, no response was received even after multiple follow-ups.Thus, our investigation is based on the initial information provided by the facility and our knowledge of our products.It was reported that an event occurred while using a pt101 airvo 2 humidifier 6 months ago.It was reported that there was a power cut and the patient almost passed away.The patient was a palliative patient in the children's ward.The patient required bagging.Subsequently, the patient was moved to the resus unit.It was also stated that the patient later demised.Without the complaint device for evaluation or any further information related to the event, it is not possible to conclusively determine what caused the reported event.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: "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply" "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.".

• 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
• MDR Report Key: 9975622
• MDR Text Key: 188170111
• Report Number: 9611451-2020-00381
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death