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

Model Number PT101

Device Problems No Flow (2991); Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of obtaining further information regarding the reported event.We will provide a follow up report upon completion of our investigation.Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that there was no flow detected from a pt101 airvo 2 humidifier in use with nasal prongs.The healthcare facility reported that the patient's saturation declined, and that the patient became cyanotic and had an apnoeic episode.The patient required respiratory resuscitation with a bag and mask.There were no further patient consequences reported.The healthcare facility further reported that the patient was critically ill and was having breathing difficulty with low saturations prior to the event.In the healthcare facility's incident report the reported injury was deemed by the healthcare facility as being low-minimal harm.It was further reported by the healthcare facility that the subject airvo was tested, and no fault was found with the device.The device was put back into service by the healthcare facility.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that there was no flow detected from a pt101 airvo 2 humidifier in use with nasal prongs.The healthcare facility reported that the patient's saturation declined, and that the patient became cyanotic and had an apnoeic episode.The patient required respiratory resuscitation with a bag and mask.There were no further patient consequences reported.The healthcare facility further reported that the patient was critically ill and was having breathing difficulty with low saturations prior to the event.In the healthcare facility's incident report the reported injury was deemed by the healthcare facility as being low-minimal harm.It was further reported by the healthcare facility that the subject airvo was tested, and no fault was found with the device.The device was put back into service by the healthcare facility.

Manufacturer Narrative

(b)(4).Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.Its intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint airvo 2 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 the product.Results: the healthcare facility reported that there was no flow detected from the airvo 2.Testing by the healthcare facility reported that there was no fault found with the complaint airvo 2.The device was returned to service by the healthcare facility.It was also reported that the patient required respiratory resuscitation with a bag and mask.The healthcare facility further reported that the patient was critically ill and was having breathing difficulty with low saturations prior to the event.No further patient consequences were reported.Conclusion: without the return of the subject device, we are unable to confirm the cause of the reported event.The healthcare facility reported that there was no fault found with the subject device.During the manufacturing process, quality control measures ensure each manufactured airvo 2 meets specification and are performed at the end of the final assembly process on 100% of manufactured units.Any unit that fails any of these tests will be rejected.The subject airvo 2 would have met the required specifications.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.

• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 15452428
• MDR Text Key: 300211561
• Report Number: 9611451-2022-00865
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: (01)09420012422354(10)2101101133(11)200504
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

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: 2101101133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2020
• 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
• Patient Outcome(s): Other