MAUDE Adverse Event Report: Fisher & Paykel Healthcare Ltd F&P Neopuff; 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	04/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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.
Event or Problem Description
A distributor in poland has reported via a fisher & paykel healthcare representative that the manometer of a rd900aeu neopuff infant resuscitator was incorrectly installed and not functional.There was no reported patient involvement.

• Brand Name: F&P Neopuff
• Common Device Name: Neopuff 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; +1(949)434-1005
• MDR Report Key: 25212181
• Report Number: 9611451-2026-01713
• Device Sequence Number: 10537010
• Product Code: FMT
• UDI-Device Identifier: 09420012410931
• UDI-Public: (01)09420012410931(10)2102321336(11)220826
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K971695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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: 2102321336
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown