Fisher & Paykel Healthcare 950N81JRecalls & reported problems
Fisher & Paykel Healthcare Limited · Neonatal Ventilator Dual Heated Circuit Kit (with accessories) · 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 09420012461216), received between Feb 22, 2025 and May 11, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
- Overfill1
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.
MalfunctionMay 11, 2025Leak/Splash; Leak/Splash
DURING DEVICE EVALUATION OF A 950N81J NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT (WITH ACCESSORIES) AT FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND, IT WAS FOUND THAT INSPIRATORY LIMB FAILED THE GAS LEAKAGE TEST DUE TO A SEVERE LEAK. 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 21999947 ↗MalfunctionFeb 22, 2025Overfill; Overfill
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE (B)(4) CHAMBER COMPLETE AUTOFEED CHAMBER AS PART OF THE 950N81J ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) WAS FOUND TO HAVE OVERFILLED ABOVE THE MAXIMUM WATER LEVEL LINE DURING PATIENT USE. IT WAS FURTHER REPORTED THAT THE 950N81J ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) WAS USED FOR 13 DAYS BEFORE THE REPORTED FAULT WAS OBSERVED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21440534 ↗
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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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