Fisher & Paykel Healthcare PT101USRecalls & reported problems

Fisher & Paykel Healthcare Limited · AIRVO 2 Humidifier · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Fisher & Paykel Airvo 2 humidifier is named in 1,061 adverse event reports, which mention 5 deaths and 4 injuries. Most reports describe alarms that fail or sound too briefly. Reports rose from 62 in the previous 12 months to 645 in the latest 12 months. 2 open recalls cover alarms: one for a power-out alarm that may not prompt reconnection, which could lead to low oxygen, and one for older units with distorted or inaudible alarms.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 1,068
Deaths reported: 5
Injuries reported: 4
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 1,068 adverse event reports that list this exact device (DI 09420012422347), received between Mar 21, 2017 and Sep 30, 2026 — classified as 5 deaths, 4 injuries, 1,059 malfunctions.

The most frequently reported specific device problem is “Defective Alarm” (712 reports).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Sep 18, 2025Class IIOpen, Classified
When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.
Z-0158-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Apr 2, 2024Class IIOpen, Classified
Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.
Z-1823-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Device problems

Defective Alarm712
No Audible Alarm351
Defective Component6
Device Alarm System6
Adverse Event Without Identified Device or Use Problem5
No Audible Prompt/Feedback5
Insufficient Device Problem Information2
Output Problem2

Patient problems

No Clinical Signs, Symptoms or Conditions890
No Patient Involvement99
No Known Impact Or Consequence To Patient52
No Consequences Or Impact To Patient18
Low Oxygen Saturation7
Insufficient Information3
Death2

Recent adverse event reports

The 25 most recent of 1,068 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Defective Alarm
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941730 ↗
MalfunctionSep 27, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909719 ↗
MalfunctionSep 27, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909718 ↗
MalfunctionSep 27, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909717 ↗
MalfunctionSep 27, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909707 ↗
MalfunctionSep 27, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909706 ↗
MalfunctionSep 24, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883996 ↗
MalfunctionSep 24, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883898 ↗
MalfunctionSep 24, 2026Defective Alarm
A healthcare facility in Indiana 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877049 ↗
MalfunctionSep 24, 2026Defective Alarm
A healthcare facility in Indiana 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877043 ↗
MalfunctionSep 24, 2026Defective Alarm
A healthcare facility in Indiana 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877042 ↗
MalfunctionSep 24, 2026Defective Alarm
A healthcare facility in Indiana 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877041 ↗
MalfunctionSep 24, 2026Defective Alarm
A healthcare facility in Indiana 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877040 ↗
MalfunctionSep 24, 2026Defective Alarm
A healthcare facility in Indiana 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877039 ↗
MalfunctionSep 24, 2026Defective Alarm
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876864 ↗
MalfunctionSep 24, 2026Defective Alarm
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876863 ↗
MalfunctionSep 24, 2026Defective Alarm
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876856 ↗
MalfunctionSep 24, 2026Defective Alarm
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876855 ↗
MalfunctionSep 24, 2026Defective Alarm
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876854 ↗
MalfunctionSep 24, 2026Defective Alarm
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876852 ↗
MalfunctionSep 24, 2026Defective Alarm
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876845 ↗
MalfunctionSep 17, 2026Defective Alarm
A healthcare facility in Canada reported via a Fisher and Paykel Healthcare (F&P) field representative 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797671 ↗
MalfunctionAug 28, 2026Defective Alarm
A healthcare facility in (b)(6) 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503977 ↗
MalfunctionAug 18, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311812 ↗
MalfunctionAug 5, 2026Defective Alarm
A healthcare facility in Canada reported via a Fisher & Paykel Healthcare (F&P) field representative 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50138095 ↗

Device details

UDI-DI	`09420012422347`
Brand	Fisher & Paykel Healthcare
Model	PT101US
Company	Fisher & Paykel Healthcare Limited
Product code	BTT · Humidifier, Respiratory Gas, (Direct Patient Interface)
Class	Class 2
FDA submission	K092846, K131895
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 10, 2026

Device type (GMDN): Professional high-flow respiratory unit, humidifying, manual

An electrically-powered device designed to deliver high-flow (exceeding peak inspiratory flow) heated and humidified ambient air or air/oxygen, at a manually set oxygen concentration (FiO2), to a spontaneously breathing patient. It is intended for use by a healthcare provider as part of noninvasive ventilation (NIV), in a peri-anaesthesia environment, or for a patient experiencing a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD)]. It typically consists of a gas flow generator, a heating element, and humidification chamber.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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