MalfunctionFMT
F&P NEOPUFF
Received Jun 30, 2026
Report 9611451-2026-02058 · MDR key 25673161
Device
Generic name
Neopuff Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AEUCatalog number
RD900AEU
Lot number
2102731188
Product problems
- Gas/Air Leak
- Pressure Problem
Patient
Not reported
- 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 CALIFORNIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE RD900AEU NEOPUFF INFANT RESUSCITATOR WAS NOT HOLDING PRESSURE AND A LEAK SOUND CAN BE HEARD INTERNALLY. THERE WAS NO REPORTED PATIENT CONSEQUENCE.