MAUDE Adverse Event Report: Fisher & Paykel Healthcare Ltd F&P Neopuff; Infant Resuscitator

Model Number	RD900AEU
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in seattle reported that the rd900aeu neopuff infant resuscitator failed the valve system test during device inspection, the pressure was observed to reach 83 cmh2o, exceeding the maximum pressure range indicated on the manometer.There was no reported patient involvement.
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.

• Brand Name: F&P Neopuff
• Common Device Name: Infant Resuscitator
• Manufacturer (Section D): Fisher & Paykel Healthcare Ltd; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): Fisher & Paykel Healthcare Ltd; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA ; +1(949)434-1005
• MDR Report Key: 50941876
• Report Number: 9611451-2026-02847
• Device Sequence Number: 15827257
• Product Code: FMT
• UDI-Device Identifier: 09420012410931
• UDI-Public: (01)09420012410931(10)2103852338(11)250709
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K971695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RD900AEU
• Device Catalogue Number: RD900AEU
• Device Lot Number: 250709048023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown