MalfunctionFMT
F&P NEOPUFF
Received May 19, 2026 · Event occurred Apr 20, 2025
Report 9611451-2026-01713 · MDR key 25212181
Device
Generic name
Neopuff Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
2102321336
Product problems
- Pressure Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or 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.