MalfunctionFMT

F&P NEOPUFF

Received Feb 23, 2026 · Event occurred Jan 14, 2026

Report 9611451-2026-00659 · MDR key 24423559

Device

Generic name

Neopuff Infant Resuscitator

Manufacturer

Fisher & Paykel Healthcare Ltd

Model number

RD900AEU

Catalog number

RD900AEU

Lot number

2101020301

Product problems

Pressure Problem

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 TEXAS HAS REPORTED THAT THE NEEDLE OF A RD900AEU NEOPUFF INFANT RESUSCITATOR WAS STUCK AT 30CMH2O. THERE WAS NO REPORTED PATIENT INVOLVEMENT.