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

Model Number PT101

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/13/2021

Event Type  Death  

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 to determine the involvement of our product in the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a critically ill patient connected to a pt101 airvo 2 humidifier had deceased.It was reported that the oxygen tube had detached, resulting in a loss of therapy.It was further reported that the patient was not being monitored and the medical cause of death was due to natural causes.The healthcare facility noted that the airvo 2 was functioning as intended.

Manufacturer Narrative

(b)(4).Method: the subject pt101 airvo 2 humidifier was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that a patient connected to a pt101 airvo 2 humidifier had deceased.It was further reported that a non-f&p oxygen tube located between the oxygen supply and the airvo 2 humidifier was incorrectly set up and detached from the oxygen supply end (not the end connected to the airvo 2), resulting in a loss of therapy.It was noted by the healthcare facility that the airvo 2 was functioning as intended.Conclusion: we are unable to determine the cause of the reported event.However, based on the information provided by the customer, the subject airvo 2 humidifier did not cause or contribute to the event as there was no fault alleged with the subject device and the disconnection occurred away from the airvo 2 as reported by the healthcare facility.It should be noted that the patient was critically ill, was not being monitored and the medical cause of death was due to natural causes.The airvo 2 user manual states that "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases." the user manual also warns the user: 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 to their oxygen supply.

Event Description

A healthcare facility in the netherlands reported via a fisher & paykel healthcare (f&p) field representative that a critically ill patient connected to a pt101 airvo 2 humidifier had deceased.It was reported that the non-f&p oxygen tube had detached, resulting in a loss of therapy.It was further reported that the airvo 2 was functioning as intended.The healthcare facility further confirmed that the oxygen tube was located between the oxygen supply and the airvo 2 humidifier and was a non-f&p product.The non-f&p oxygen tube was incorrectly set up, resulting in its detachment at the oxygen supply end (not the end connected to the airvo 2).The healthcare facility also noted that the patient was not being monitored and the medical cause of death was due to natural causes.

• 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 ; 9494534002
• MDR Report Key: 12994626
• MDR Text Key: 282179656
• Report Number: 9611451-2021-01397
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2100669450(11)190108
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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: 2100669450
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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
• Patient Outcome(s): Death