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

Model Number PT101

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/20/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).The pt101 airvo 2 humidifier user manual states that the "airvo 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.The hospital has stated that the device behaved as it should.We are currently attempting to obtain more information from the hospital and to retrieve the subject airvo humidifier for assessment.We will provide a follow-up/final report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a patient was transferred from the emergency department to the ward, where she arrested and subsequently passed away.The transfer was done while being connected to a pt101 airvo 2 humidifier (60l/min at 92 % o2).The hospital further stated that "the airvo 2 behaved as it should and lost power once disconnected from the mains.The o2 was still attached to the device during transfer at a high volume flow.".

Event Description

A hospital in the uk reported via a fisher & paykel healthcare (f&p) field representative that a patient was transferred from the emergency department to the ward, where they arrested and subsequently passed away.The patient was transferred while using a pt101 airvo 2 humidifier (60l/min at 92 % o2) without an uninterruptible power supply.The hospital further stated that "the airvo 2 behaved as it should and lost power once disconnected from the mains.The o2 was still attached to the device during transfer at a high volume flow.".

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 patient's primary diagnosis was viral pneumonia resulting in an hospital admission.Fisher & paykel healthcare's (f&p) clinical assessment of the information provided by the hospital regarding the patient's existing medical conditions revealed that the patient had a complex and declining clinical profile.Furthermore, the patient had a 'do-not-resuscitate (dnr)' order.F&p understands dnr is an instructions in a patient's records that cardiopulmonary resuscitation (cpr) is not to be performed should cardiorespiratory arrest occur (1).It was further reported by the hospital that prior to the transfer of the patient from the emergency department to the ward, the patient demonstrated signs of respiratory decline.Information from the hospital also suggested that the staff was aware that there was no uninterruptible power supply (ups) battery backup.Despite this, the airvo device was unplugged and there was no other oxygen support provided while the patient was transferred from the emergency department to the ward.The hospital has stated that the airvo device behaved as it should.Method: the complaint pt101 airvo 2 humidifier was received at f&p new zealand for investigation.The unit was visually inspected for defects and functionally tested for an extended period.Results: during testing, the airvo 2 humidifier powered on and was found to be fully functioning.There was no fault found with the device.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 device (attached to an oxygen cylinder) was unplugged when the patient was transferred, resulting in little oxygen being supplied to the patient.The patient was likely dependent on the oxygen supply and had demonstrated signs of respiratory decline prior to the transfer.No further intervention actions were taken due to dnr.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.(1) ip, j.K., hirsch, n., yentis, s.M.(2000).Anaesthesia and intensive care a-z e-book: an encyclopedia of principles and practice.Churchill livingstone elsevier (p.189).

• 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: 9485443
• MDR Text Key: 171829640
• Report Number: 9611451-2018-01214
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: (01)09420012422354(10)2100414362(11)180214
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2100414362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death