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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing f&p's investigation.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 in (b)(6) reported that a pt301 airvo 3 humidifier (airvo 3) generated an alarm.The nature of the alarm suggests there may be a potential issue with the subject device's audible alarm.During device evaluation at the fisher & paykel healthcare (f&p) regional office in the usa, it was found that there was no audible alarm.There was no reported patient involvement.
Event or Problem Description
A healthcare facility in new jersey reported that a pt301 airvo 3 humidifier (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.During device evaluation at the fisher & paykel healthcare (f&p) regional office in the usa, it was found that there was no audible alarm.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Corrected data: a1, b4, b5, g3, g6, h2, h3, h6.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.F&p's investigation is based on the information obtained from the healthcare facility, f&p's evaluation of the subject device, previous investigations of similar complaints, and f&p's knowledge of the product.Results: during testing it was found that the airvo 3 did not have an audible alarm, confirming the reported event.It was identified that the issue was due to a faulty speaker.The speaker is a supplied component that is assembled into the airvo 3.There was no patient involvement reported by the healthcare facility.Conclusion: f&p's investigation was unable to determine the exact cause of the reported event.Based on the information provided by the healthcare facility, f&p's investigation, and knowledge of the product, a possible cause of the speaker fault was due to the speaker component being out of specification.The airvo 3 will generate a visual alarm in the presence of an inaudible alarm.The alarm in the reported event prevents the operation of the subject device and alerts the user to take appropriate and timely action.There was no patient involvement reported by the healthcare facility.The user instructions which accompany the airvo 3 provide guidance on troubleshooting alarms generated by the device.The user instructions state the following: - device fault (fault x.X.X): "a technical fault has occurred, and the patient may need prompt attention.Restart the device to clear the fault condition.If the issue persists, contact your service representative." the user instructions also state: - "make sure the auditory alarm signal is audible to the operator who will respond to alarms by following the instructions in section 7.5 to test the alarm before starting therapy." - "do not use the airvo 3 if it fails [the 7.5 checking the alarm system] test.Contact your fisher & paykel healthcare representative." - "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 airway bypassed." - "the airvo 3 is not intended to provide total ventilatory requirements of the patient and is not for use during field transport." - "the airvo 3 is not intended for life support.Do not use airvo 3 on patients who cannot tolerate a brief interruption of therapy." - "appropriate patient monitoring is required for all patients using the airvo 3.".

• 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 ; 9494341005
• MDR Report Key: 22801292
• Report Number: 9611451-2025-00761
• Device Sequence Number: 7656627
• Product Code: QAV
• UDI-Device Identifier: 09420012466662
• UDI-Public: (01)09420012466662(10)2102821804(11)231007
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 2102821804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2023
• 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