F&P Neopuff RD900AFURecalls & reported problems
Fisher & Paykel Healthcare Limited · Neopuff™ Infant T-Piece Resuscitator FR · Class 2
All models of F&P Neopuff (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 09420012410948), received between Oct 1, 2020 and Oct 23, 2025 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (10 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 Problem10
- Break7
- Output Problem3
- Crack1
- Defective Component1
- Mechanical Problem1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Patient Involvement1
- Pneumothorax1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE HAS REPORTED THAT A RD900AFU NEOPUFF INFANT RESUSCITATOR DOES NOT RETAIN THE SETTINGS DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373013 ↗MalfunctionAug 4, 2025Break; Break
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT AN RD900AFU NEOPUFF INFANT RESUSCITATOR'S GAS OUTLET PORT WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22710362 ↗MalfunctionJun 23, 2025Break; Break
A HEALTHCARE FACILITY IN FRANCE HAS REPORTED THAT AN RD900AFU NEOPUFF INFANT RESUSCITATOR'S GAS INLET AND OUTLET PORTS WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22312631 ↗MalfunctionJun 19, 2025Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE RD900AFU NEOPUFF INFANT RESUSCITATOR HAS MAXIMUM PRESSURE PROBLEM. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22290723 ↗MalfunctionJul 10, 2024Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE MANOMETER NEEDLE OF AN RD900AFU NEOPUFF INFANT RESUSCITATOR WAS INTERMITTENTLY BLOCKED AND WOULD NOT GO BACK TO ZERO. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19716951 ↗MalfunctionJun 21, 2024Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE MANOMETER NEEDLE OF AN RD900 NEOPUFF INFANT RESUSCITATOR WAS MOVING SLOWLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581909 ↗MalfunctionApr 16, 2024Break; Break
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE PEAK INSPIRATORY CONTROL PORT OF AN RD900 NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19122555 ↗MalfunctionJan 17, 2024Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE PRESSURE READINGS ON AN RD900 NEOPUFF INFANT RESUSCITATOR WAS FLUCTUATING. IT WAS FURTHER REPORTED THE PATIENT WAS TREATED FOR A PNEUMOTHORAX. THIS WAS SUCCESSFULLY TREATED VIA DRAINAGE. THERE WERE NO FURTHER PATIENT CONSEQUENCES REPORTED.
Patient problems: Pneumothorax
MAUDE report 18531946 ↗MalfunctionJan 10, 2024Break; Break
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE OUTLET PORT ON AN RD900 NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18490142 ↗MalfunctionJun 22, 2023Break; Crack; Break; Crack
A HEALTHCARE FACILITY IN BELGIUM REPORTED THAT THE GAS INLET PORT OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17188054 ↗MalfunctionMay 2, 2023Break; Break
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE INLET PORT OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16855969 ↗MalfunctionJul 25, 2022Defective Component; Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE MANOMETER OF AN RD900 NEOPUFF INFANT RESUSCITATOR WAS FAULTY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15099776 ↗MalfunctionJul 20, 2022Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER AND PAYKEL (F&P) REPRESENTATIVE THAT PRESSURE OF AN RD900 NEOPUFF INFANT RESUSCITATOR UNIT WOULD NOT REACH 30CM AT 8L PER MINUTE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15071119 ↗MalfunctionJun 1, 2022Output Problem; Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE PRESSURE OF AN RD900 NEOPUFF INFANT RESUSCITATOR UNIT WOULD NOT INCREASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14570674 ↗MalfunctionMay 26, 2022Output Problem; Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MANOMETER OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS FAULTY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14506649 ↗MalfunctionMay 25, 2022Output Problem; Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT PRESSURE OF AN RD900 NEOPUFF INFANT RESUSCITATOR UNIT WOULD NOT PASS 20MBAR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14493978 ↗MalfunctionNov 2, 2021Physical Resistance/Sticking; Mechanical Problem; Physical Resistance/Sticking
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE MANOMETER NEEDLE OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS STUCK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12741648 ↗MalfunctionOct 1, 2020Break
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE OUTLET PORT OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10617519 ↗
Other Warmer, Infant Radiant devices
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- Resuscitaire Radiant Warmer (RW82, RW82 VHA) MU20503Draeger Medical Systems, Inc. · Warmer, Infant Radiant1 recall3 deaths15 reports
- Panda iRes WarmerDatex-Ohmeda, Inc. · WARMER, INFANT RADIANT34 reports
- Giraffe WarmerDatex-Ohmeda, Inc. · WARMER, INFANT RADIANT27 reports
- DeRoyal HNICU-37Deroyal Industries, Inc. · WARMER, INFANT RADIANT25 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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