MalfunctionFMT
F&P Neopuff
Received Jun 5, 2026
Report 9611451-2026-01808 · MDR key 25403444
Device
Generic name
Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
100202
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE GAS OUTLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. 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.