MalfunctionFMT
F&P NEOPUFF
Received Mar 18, 2026 · Event occurred Feb 14, 2026
Report 9611451-2026-00995 · MDR key 24634412
Device
Generic name
Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
2100467270
Product problems
- Pressure Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTHCARE FACILITY IN OREGON REPORTED THAT THE MANOMETER OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WOULD NOT INCREASE PRESSURE ABOVE 30. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Additional Manufacturer Narrative
(B)(4). 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.