FISHER & PAYKEL HEALTHCARE
Received Mar 2, 2026 · Event occurred Feb 3, 2026
Report 9611451-2026-00760 · MDR key 24486160
Device
Generic name
Neopuff Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
090317001069
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. SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING.
Description of Event or Problem
A HEALTHCARE FACILITY IN NEW YORK HAS REPORTED THAT THE PEAK INSPIRATORY PRESSURE OF A RD900AEU NEOPUFF INFANT RESUSCITATOR WAS NOT WORKING. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE MANOMETER NEEDLE DOES NOT MOVE WITH INCREASE IN PRESSURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.