MalfunctionFMT

F&P NEOPUFF

Received Jun 15, 2026

Report 9611451-2026-01904 · MDR key 25500065

Device

Generic name

Infant Resuscitator

Manufacturer

Fisher & Paykel Healthcare Ltd

Model number

RD900AFU

Catalog number

RD900AFU

Lot number

2100478254

Product problems

Pressure Problem

Patient

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 REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN RD900AFU NEOPUFF INFANT RESUSCITATOR HAD PRESSURE ADJUSTMENT ISSUE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.