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

Model Number	RD900AEU
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that the peak inspiratory pressure knob of an rd900aeu neopuff infant resuscitator did not rotate during the biomed acceptance test.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.
Event or Problem Description
A healthcare facility in australia reported reported via a fisher & paykel healthcare (f&p) field representative that an rd900aeu neopuff infant resuscitator failed the acceptance test due to the the peak inspiratory pressure knob not rotating.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the subject device, rd900aeu neopuff infant resuscitator was returned to fisher & paykel healthcare (f&p) new zealand for evaluation.Our investigation is thus based on the evaluation of the returned device, information provided by the healthcare facility, and our knowledge of the product.Results: visual inspection and disassembly of the device were performed as part of the investigation.Upon detailed examination of the knob assembly, it was found that the knob threads and valve body threads were misaligned, preventing the rotation of the knob.Conclusion: based on the evaluation of the subject device, the reported fault was likely caused due to excess of glue applied during the manufacturing process.The neopuff is a portable, reusable device used to assist in the delivery of respiratory breaths to infants until adequate spontaneous breathing occurs.The neopuff user instructions state that the user should "check manometer reads zero with no gas flow" and check the pressure settings "prior to every use of the neopuff".Furthermore, the product technical manual also instructs to complete performance testing prior to first use of the device.

• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; +1(949)434-1005
• MDR Report Key: 25250247
• Report Number: 9611451-2026-01700
• Device Sequence Number: 16088890
• Product Code: FMT
• UDI-Device Identifier: 09420012410931
• UDI-Public: (01)09420012410931(10)2103861427(11)250715
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K971695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: 2103861427
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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