MalfunctionFMT
F&P NEOPUFF
Received Jul 9, 2026
Report 9611451-2026-02101 · MDR key 25758107
Device
Generic name
Infant Resuscitator
Manufacturer
Fisher & Paykel Healthcare LtdModel number
RD900AFUCatalog number
RD900AFU
Lot number
000274
Product problems
- Pressure Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE NEEDLE IN THE MANOMETER OF AN RD900AFU NEOPUFF INFANT RESUSCITATOR BECOMES STUCK AT MAXIMUM PRESSURE AND MOVES SLOWLY WHEN PRESSURE IS RELEASED.THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
(b)(4).SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING.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.