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

Model Number	PT101US
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in canada reported that the power out alarm of the pt101 airvo 2 humidifier (airvo 2) sounded for less than 120 seconds.This was found while the subject airvo 2 was out of use and not on a patient.This was reported subsequent to a field safety notice informing users of a change to the disinfection kit user manual of the airvo 2 to include a regular test of the power out alarm, to be carried out in between each patient use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
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 pt101 airvo 2 humidifier (airvo 2) 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 is not intended for life support, and appropriate patient monitoring must be used at all times.

• 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; +1(949)434-1005
• MDR Report Key: 50876845
• Report Number: 9611451-2026-02779
• Device Sequence Number: 16131188
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: (01)09420012422347(10)2101397558(11)201120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Device Model Number: PT101US
• Device Catalogue Number: PT101US
• Device Lot Number: 2101397558
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9611451-09/10/2025-001-C
• Patient Sequence Number: 1
• Patient Sex: Unknown