MAUDE Adverse Event Report: Fisher & Paykel Healthcare Ltd Fisher & Paykel Healthcare; Respiratory Humidifier

Model Number	PT301US
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).F&p have requested for further information from the healthcare facility, including more details on patient consequences, the sequence of events, and for the return of the subject device.F&p will provide a follow up report upon completion of f&p's investigation.Product background: the airvo 3 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.This includes patients who have had upper airways bypassed.The flow may be from 2 - 70 l/min depending on the patient interface.The airvo 3 is for patients in hospitals and subacute facilities.The airvo 3 is not intended for life support.The airvo 3 can deliver these high flow gases through nasal cannula to augment the breathing of spontaneously breathing neonate, infant, child, adolescent and adult patients suffering from respiratory distress and/or hypoxemia in the hospital setting.The airvo 3 is not intended to provide total ventilatory requirements of the patient and is not for use during field transport.
Event or Problem Description
A healthcare facility reported via a fisher & paykel healthcare (f&p) field representative that a pt301 airvo 3 generated a visual alarm.The nature of the visual alarm suggests there may be a potential issue with the subject device's audible alarm.The healthcare facility reported that the patient experienced desaturation.F&p have requested for further information from the healthcare facility, including more details on patient consequences, the sequence of events, and for the return of the subject device.F&p will provide a follow up report upon completion of f&p's investigation.
Event or Problem Description
A healthcare facility in alaska reported via a fisher & paykel healthcare (f&p) field representative that a pt301 airvo 3 generated a visual alarm.The nature of the visual alarm suggests there may be a potential issue with the subject device's audible alarm.The healthcare facility reported that the patient experienced desaturation.It was later stated by the healthcare facility that "nothing serious happened".F&p made multiple requests for further information from the healthcare facility, including the sequence of events, photographs and diagrams of the device set up of the subject device.However, the healthcare facility did not provide this information.
Additional Manufacturer Narrative
(b)(4).Corrected data: b4,b5,d9,g3,g6,h2,h3,h6,h11.Product background: the airvo 3 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.This includes patients who have had upper airways bypassed.The flow may be from 2 - 70 l/min depending on the patient interface.The airvo 3 is for patients in hospitals and subacute facilities.The airvo 3 is not intended for life support.The airvo 3 can deliver these high flow gases through nasal cannula to augment the breathing of spontaneously breathing neonate, infant, child, adolescent and adult patients suffering from respiratory distress and/or hypoxemia in the hospital setting.The airvo 3 is not intended to provide total ventilatory requirements of the patient and is not for use during field transport.Method: the subject airvo 3 was received by fisher & paykel healthcare (f&p) where it was inspected by a trained f&p investigation engineer.The device was performance tested and the audible alarm function was checked.Results: during testing it was found that the airvo 3 did have an audible alarm.The healthcare facility reported that the patient experienced desaturation.It was later stated by the healthcare facility that "nothing serious happened".F&p made multiple requests for further information from the healthcare facility, including the sequence of events, photographs and diagrams of the device set up of the subject device.However, the healthcare facility did not provide this information.Conclusion: f&p's investigation was unable to determine what may have caused the reported event as the audible alarm of the subject airvo 3 was working as intended.

• Brand Name: Fisher & Paykel Healthcare
• Common Device Name: Respiratory 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; +1(949)434-1005
• MDR Report Key: 24465974
• Report Number: 9611451-2026-00747
• Device Sequence Number: 9581139
• Product Code: QAV
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K221338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PT301US
• Device Catalogue Number: PT301US
• Device Lot Number: 2103524785
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown