F&P Neopuff RD900AEURecalls & reported problems
Fisher & Paykel Healthcare Limited · NEOPUFF INFANT RESUSCITATOR EN · Class 2
All models of F&P Neopuff (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Fisher & Paykel Neopuff infant resuscitator has 422 reports, with no deaths and no injuries. Most reports describe pressure problems, often with the pressure gauge needle sticking or moving slowly, and many describe broken parts such as gas outlet ports. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 433
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 433 adverse event reports that list this exact device (DI 09420012410931), received between Nov 24, 2016 and Sep 30, 2026 — classified as 433 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (284 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Pressure Problem284
- Break143
- Physical Resistance/Sticking9
- Loss of or Failure to Bond8
- Mechanical Problem8
- Output Problem8
- Defective Component6
- Defective Device5
Patient problems
- No Clinical Signs, Symptoms or Conditions384
- No Patient Involvement26
- No Known Impact Or Consequence To Patient23
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 433 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break; Pressure Problem
A distributor in India reported reported via a Fisher & Paykel Healthcare (F&P) field representative that the gas inlet port of an RD900AEU Neopuff Infant Resuscitator was cracked.There was no reported patient consequence.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941986 ↗MalfunctionSep 30, 2026Pressure Problem
A healthcare facility in Seattle reported that the RD900AEU Neopuff Infant Resuscitator failed the valve system test during device inspection, the pressure was observed to reach 83 cmH2O, exceeding the maximum pressure range indicated on the manometer.There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941876 ↗MalfunctionSep 21, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847241 ↗MalfunctionSep 15, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782307 ↗MalfunctionSep 10, 2026Break; Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724453 ↗MalfunctionSep 10, 2026Physical Resistance/Sticking
A distributor in South Africa reported that the Peak Inspiratory Pressure knob and or the Max Pressure Relief knob of four RD900AEU Neopuff Infant Resuscitator was not rotating smoothly during acceptance checks. There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50704330 ↗MalfunctionSep 10, 2026Break
A healthcare facility in Texas reported that the gas outlet port of a RD900AEU Neopuff Infant Resuscitator was broken. There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50704329 ↗MalfunctionSep 4, 2026Physical Resistance/Sticking
A distributor in South Africa reported that the Peak Inspiratory Pressure knob and or Max Pressure Relief knob of twenty-five RD900AEU Neopuff Infant Resuscitator was not rotating smoothly during acceptance checks. There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50601047 ↗MalfunctionSep 3, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596115 ↗MalfunctionSep 3, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596112 ↗MalfunctionSep 3, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596108 ↗MalfunctionSep 1, 2026Break; Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554043 ↗MalfunctionAug 12, 2026Break; Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217736 ↗MalfunctionJul 27, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003824 ↗MalfunctionJul 21, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25899729 ↗MalfunctionJul 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25823961 ↗MalfunctionJun 30, 2026Gas/Air Leak; Pressure Problem
A DISTRIBUTOR IN CALIFORNIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE RD900AEU NEOPUFF INFANT RESUSCITATOR WAS NOT HOLDING PRESSURE AND A LEAK SOUND CAN BE HEARD INTERNALLY. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673161 ↗MalfunctionJun 30, 2026Break
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF TWO RD900AEU NEOPUFF INFANT RESUSCITATOR WERE BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673157 ↗MalfunctionJun 5, 2026Break
A DISTRIBUTOR IN TEXAS REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE GAS INLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25406732 ↗MalfunctionMay 26, 2026Pressure Problem
A VENDOR IN WASHINGTON REPORTED, ON BEHALF OF A HEALTHCARE FACILITY, THAT DURING PREVENTIVE MAINTENANCE OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR, THE PEAK INSPIRATORY PRESSURE COULD NOT BE ADJUSTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25291174 ↗MalfunctionMay 21, 2026Physical Resistance/Sticking
A HEALTHCARE FACILITY IN AUSTRALIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE PEAK INSPIRATORY PRESSURE KNOB OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR DID NOT ROTATE DURING THE BIOMED ACCEPTANCE TEST. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25250247 ↗MalfunctionMay 19, 2026Pressure Problem
A DISTRIBUTOR IN POLAND HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE MANOMETER OF A RD900AEU NEOPUFF INFANT RESUSCITATOR WAS INCORRECTLY INSTALLED AND NOT FUNCTIONAL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25212181 ↗MalfunctionApr 15, 2026Pressure Problem; Physical Resistance/Sticking
A DISTRIBUTOR IN SOUTH AFRICA REPORTED THAT THE MAXIMUM PRESSURE RELIEF KNOB AND THE PEAK INSPIRATORY PRESSURE KNOB OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR ARE NOT ROTATING SMOOTHLY. IT WAS FURTHER REPORTED THAT 12 OTHER UNITS WERE AFFECTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24880484 ↗MalfunctionApr 8, 2026Loose or Intermittent Connection
DURING DEVICE EVALUATION OF THE SUBJECT DEVICE, RD900AEU NEOPUFF INFANT RESUSCITATOR AT FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN INDIA, IT WAS FOUND THAT THE MANOMETER NUT HAS BECOME LOOSE AND CAME OFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24812481 ↗MalfunctionMar 24, 2026Pressure Problem
A DISTRIBUTOR IN SOUTH AFRICA HAS REPORTED THAT THE MANOMETER SPIKES WHEN ADJUSTING THE MAXIMUM PRESSURE RELIEF KNOB OF A RD900AEU NEOPUFF INFANT RESUSCITATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24676392 ↗
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- F&P Neopuff RD900AFUFisher & Paykel Healthcare Limited · Warmer, Infant Radiant18 reports
- DeRoyal 81-010400Deroyal Industries, Inc. · WARMER, INFANT RADIANT5 reports
- DeRoyal HNICU-03Deroyal Industries, Inc. · WARMER, INFANT RADIANT5 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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