Fisher & Paykel Healthcare PT301USRecalls & reported problems
Fisher & Paykel Healthcare Limited · Respiratory Support Device · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 09420012466662), received between Jul 8, 2025 and Apr 30, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (6 reports).
1 FDA recall record name this device's identifier, 1 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
Recalls naming this device
- Aug 7, 2024Class IIOpen, Classified
Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.
Z-3262-2024 · Root cause: Software change control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Audible Alarm6
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
- Low Oxygen Saturation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE 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. 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 25053621 ↗MalfunctionMar 25, 2026No Audible Alarm
A healthcare facility in (b)(6) reported that a PT301 Airvo 3 generated an alarm. The nature of the alarm suggests there may be a potential issue with the subject device's audible alarm.There was no patient involvement as the issue was found whilst the subject device was not in use on a patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24694621 ↗MalfunctionFeb 26, 2026No Audible Alarm
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.
Patient problems: Insufficient Information; Low Oxygen Saturation
MAUDE report 24465974 ↗MalfunctionAug 13, 2025No Audible Alarm; No Audible Alarm
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22801292 ↗MalfunctionJul 23, 2025No Audible Alarm; Insufficient Device Problem Information; No Audible Alarm; Insufficient Device Problem Information
A HEALTHCARE FACILITY IN GEORGIA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE 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. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE SUBJECT DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22584183 ↗MalfunctionJul 8, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN NEW JERSEY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A PT301 AIRVO 3 DID NOT HAVE AN AUDIBLE ALARM. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22454709 ↗
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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