F&P Airvo 900PT561Recalls & reported problems
Fisher & Paykel Healthcare Limited · Heated Breathing Tube and Chamber Kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Fisher & Paykel Airvo 900 heated breathing tube and chamber kit supplies humidified air to patients on ventilators. The 56 reports mostly describe cracked or melted plastic parts and water leaking or splashing out of the chamber, often noticed during use;1 report describes a death and no reports describe injuries. Most reports come from facilities in China. No recalls name this device.
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
- 56
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 09420012433794), received between Jun 19, 2020 and May 19, 2026 — classified as 1 death, 55 malfunctions.
The most frequently reported specific device problem is “Crack” (30 reports).
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
Most reported problems
Device problems
- Crack30
- Leak/Splash14
- Fluid/Blood Leak13
- Melted8
- Overfill3
- Gas/Air Leak2
- Ambient Temperature Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- Low Oxygen Saturation3
- Aspiration/Inhalation1
- Cancer1
- Fibrosis1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Crack; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND DAMAGED AND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25225138 ↗MalfunctionMar 30, 2026Fluid/Blood Leak; Leak/Splash
A HEALTHCARE FACILITY IN CHINA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND LEAKING WATER AT THE BASE OF THE CHAMBER. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24722810 ↗MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND LEAKING WATER. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23847163 ↗MalfunctionDec 10, 2025Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND DAMAGED BEFORE 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 23774907 ↗MalfunctionDec 8, 2025Melted; Melted
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HEATED BREATHING TUBE AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND MELTED. THE DISTRIBUTOR REPORTED THAT THE DEVICE WAS NOT IN USE BY THE PATIENT AT THE TIME OF THE REPORTED EVENT AS THE PATIENT HAD LEFT THE WARD MIDWAY THROUGH RECEIVING THERAPY. THE DISTRIBUTOR FURTHER REPORTED THAT THE AIRVO 2 UNIT USED WITH THE SUBJECT HEATED BREATHING TUBE WAS NOT SHUT DOWN AND THE SUBJECT HEATED BREATHING TUBE HAD BEEN COVERED WITH A BLANKET DURING THE REPORTED EVENT, CAUSING THE TUBE TO MELT. 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 23752990 ↗MalfunctionNov 26, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND DAMAGED AT THE CHAMBER DOME AND LEAKING WATER DURING PATIENT USE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE SUBJECT DEVICE WAS DESTROYED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23662800 ↗MalfunctionNov 18, 2025Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS A PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND DAMAGED DURING PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED BY THE HEALTHCARE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23589980 ↗MalfunctionAug 12, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND DAMAGED AT THE CHAMBER DOME DURING PATIENT USE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE SUBJECT DEVICE WAS DESTROYED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22780739 ↗MalfunctionAug 5, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND LEAKING WATER. 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 22723507 ↗MalfunctionJun 26, 2025Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND WITH A CHAMBER CRACK. 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 22334211 ↗MalfunctionJun 15, 2025Crack; Crack
A DISTRIBUTOR IN CHINA REPORTED THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND WITH A CHAMBER CRACK BEFORE 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 22208659 ↗MalfunctionJun 5, 2025Crack; Leak/Splash; Crack; Leak/Splash
A HEALTHCARE FACILITY IN TAIWAN REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE AUTOFILL CHAMBER AS A PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND DAMAGED BEFORE 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 22154782 ↗MalfunctionApr 22, 2025Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND DAMAGED BEFORE 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 21887394 ↗MalfunctionApr 17, 2025Leak/Splash; Leak/Splash
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND LEAKING DURING PATIENT USE. THE SUBJECT DEVICE WAS REPLACED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21854760 ↗MalfunctionMar 6, 2025Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND DAMAGED AT THE DOME OF THE CHAMBER BEFORE 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 21543111 ↗MalfunctionMar 6, 2025Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND WITH A CHAMBER CRACK BEFORE 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 21540281 ↗MalfunctionMar 6, 2025Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND WITH A CHAMBER CRACK BEFORE 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 21540248 ↗MalfunctionMar 6, 2025Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE DOME OF THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND WITH A CHAMBER CRACK DURING USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21538759 ↗MalfunctionFeb 21, 2025Leak/Splash; Leak/Splash
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND LEAKING WATER AT THE BASE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21431696 ↗MalfunctionJan 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND LEAKING WATER AT THE BASE. 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 21280377 ↗MalfunctionOct 8, 2024Melted; Material Too Soft/Flexible; Melted; Material Too Soft/Flexible
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN INDIA VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HEATED BREATHING TUBE AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND MELTED DURING USE. THE HEALTHCARE FACILITY LATER REPORTED THAT THE SUBJECT DEVICE HAD BEEN IN USE FOR ONE DAY. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT WAS "HAVING DIFFICULTIES IN BREATHING AS SATURATION WAS DROPPING". THE HEALTHCARE FACILITY ALSO REPORTED THAT THEY REPLACED THE SUBJECT DEVICE. THE HEALTHCARE FACILITY REPORTED NO FURTHER PATIENT CONSEQUENCES.
Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions
MAUDE report 20402217 ↗MalfunctionAug 9, 2024Crack; Leak/Splash; Crack; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF THE HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS A PART OF THE 900PT561 AIRVO HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND CRACKED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19946402 ↗MalfunctionJul 22, 2024Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF THE HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS A PART OF THE 900PT561 AIRVO HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND CRACKED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19802749 ↗MalfunctionMay 28, 2024Fluid/Blood Leak; Fluid/Blood Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE (B)(6) HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND LEAKING WATER FROM THE BASE OF THE CHAMBER BEFORE 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 19412494 ↗MalfunctionApr 3, 2024Crack; Leak/Splash; Crack; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT WAS FOUND WITH A CHAMBER CRACK AND LEAKING DURING PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19038919 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
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- MR850 MR850JHUFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)93 reports
- HUDSON RCI HUD42500Medline Industries, Inc. · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
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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
- 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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