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FISHER & PAYKEL HEALTHCARE 900RD010Recalls & reported problems

Fisher & Paykel Healthcare Limited · Classic T-Piece Circuit · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09420012429933), received between Apr 28, 2024 and Apr 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Pressure Problem” (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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 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 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Pressure Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 28, 2024Pressure Problem; Pressure Problem

    A HEALTHCARE FACILITY IN UNITED KINGDOM REPORTED VIA THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) THAT A DEVIATION IN THE POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALUE WAS OBSERVED DURING THE RESUSCITATION OF A PATIENT USING A (B)(4). ADJUSTABLE T PIECE RESUSCITATION CIRCUIT. THE PEEP, WHICH SHOULD IDEALLY BE MAINTAINED AT 10 CM H2O WAS NOTED TO BE AT AN ELEVATED LEVEL OF 30 CM H2O. THERE WERE NO PATIENT CONSEQUENCES REPORTED. F&P HAVE REQUESTED FURTHER INFORMATION ABOUT THE EVENT AND PATIENT CONDITION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19199320 ↗

Other Ventilator, Emergency, Powered (Resuscitator) devices

All Ventilator, Emergency, Powered (Resuscitator) devices →

Sources and updates

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