MalfunctionFMT

F&P NEOPUFF

Received Apr 29, 2026

Report 9611451-2026-01518 · MDR key 25038451

Device

Generic name

Neopuff Infant Resuscitator

Manufacturer

Fisher & Paykel Healthcare Ltd

Model number

RD900AFU

Catalog number

RD900AFU

Lot number

2100250721

Product problems

Gas/Air Leak

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

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.

Description of Event or Problem

A HEALTHCARE FACILITY IN FRANCE HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A RD900AFU NEOPUFF INFANT RESUSCITATOR WAS LEAKING. THERE WAS NO REPORTED PATIENT CONSEQUENCE.