Fisher & Paykel Healthcare MR340ERecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09420012401588), received between Jan 9, 2023 and Jun 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (1 report).
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
- Gas/Air Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2025Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR IN INDONESIA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT AN MR340E REUSABLE HUMIDIFICATION CHAMBER FAILED THE VENTILATOR PRE-USE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22208718 ↗MalfunctionJan 9, 2023Leak/Splash; Leak/Splash
A DISTRIBUTOR IN CHINA REPORTED THAT A MR340E REUSABLE HUMIDIFICATION CHAMBER WAS FOUND LEAKING WATER BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16127918 ↗
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- 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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