Fisher & Paykel Healthcare MR370Recalls & reported problems
Fisher & Paykel Healthcare Limited · Reusable humidification chamber · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 09420012401618), received between Dec 29, 2020 and Mar 30, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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
- Fluid/Blood Leak4
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Fluid/Blood Leak
A DISTRIBUTOR IN CHINA REPORTED THAT A MR370 REUSABLE HUMIDIFICATION CHAMBER 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 24724750 ↗MalfunctionOct 22, 2024Crack; Crack
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR370 REUSABLE HUMIDIFICATION CHAMBER DOME WAS FOUND CRACKED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20502091 ↗MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
A HEALTHCARE FACILITY IN CHINA REPORTED THAT A MR370 REUSABLE HUMIDIFICATION CHAMBER WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19048067 ↗MalfunctionNov 21, 2022Crack; Crack
A HEALTHCARE FACILITY IN CHINA REPORTED THAT A MR370 REUSABLE HUMIDIFICATION CHAMBER WAS FOUND CRACKED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15840932 ↗MalfunctionMar 31, 2021Fluid/Blood Leak
A DISTRIBUTOR IN CHINA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A MR370 REUSABLE HUMIDIFICATION CHAMBER WAS LEAKING WATER FROM THE CHAMBER BASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11600597 ↗MalfunctionDec 29, 2020Fluid/Blood Leak
A DISTRIBUTOR IN CHINA REPORTED THAT THE MR370 REUSABLE HUMIDIFICATION CHAMBER WAS LEAKING WATER FROM THE CHAMBER BASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11092497 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
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- 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
- F&P Airvo 900PT561Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)1 death56 reports
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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