MalfunctionFMT
F&P NEOPUFF
Received Apr 21, 2026 · Event occurred Mar 20, 2026
Report 9611451-2026-01413 · MDR key 24948333
Device
Generic name
Neopuff Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
2103046793
Product problems
- Pressure Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTHCARE FACILITY IN (B)(6) HAS REPORTED THAT THE PRESSURE OF A RD900AEU NEOPUFF INFANT RESUSCITATOR WILL NOT GO ABOVE 10CMH2O EVEN WHEN THE PRESSURE IS SET AT 35CMH2O. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
(B)(6). FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.