FISHER & PAYKEL HEALTHCARE RD1300-10Recalls & reported problems
Fisher & Paykel Healthcare Limited · Ergonomic T-Piece Circuit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09420012429988), received between Nov 24, 2024 and Oct 23, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (5 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
- Pressure Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Pressure Problem; Pressure Problem
A DISTRIBUTOR IN COLOMBIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE PEEP VALVE OF THE RD1300-10 NEOPUFF T-PIECE CIRCUIT WAS NOT MOVING . THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373014 ↗MalfunctionMay 16, 2025Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT IT WAS HARD TO TURN OR ADJUST THE PEEP VALVE OF THREE OF THE RD1300-10 NEOPUFF T-PIECE CIRCUITS. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE RD1300-10 NEOPUFF T-PIECE CIRCUITS WERE DISCARDED AND ARE NOT AVAILABLE FOR EVALUATION. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22033310 ↗MalfunctionDec 4, 2024Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT IT WAS VERY HARD TO ROTATE THE PEEP VALVE OF A RD1300-10 NEOPUFF T-PIECE CIRCUIT. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20840842 ↗MalfunctionNov 28, 2024Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT PEEP VALVE OF 4 UNITS OF RD1300-10 NEOPUFF T-PIECE CIRCUITS WERE DIFFICULT TO ROTATE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20808223 ↗MalfunctionNov 24, 2024Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE VALVES OF 42 UNITS RD1300 NEOPUFF T-PIECE CIRCUITS WERE NOT MOVING. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20768476 ↗
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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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