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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 2 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

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