MalfunctionFMT
F&P NEOPUFF
Received Apr 8, 2026
Report 9611451-2026-01248 · MDR key 24824035
Device
Generic name
Neopuff Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
120316
Product problems
- Pressure Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTHCARE FACILITY IN OHIO HAS REPORTED THAT A RD900AEU NEOPUFF INFANT RESUSCITATOR WOULD NOT MAINTAIN PRESSURE. 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. SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING.