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	02/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the subject device, rd900aeu neopuff infant resuscitator was not returned to fisher & paykel healthcare (f&p).Our investigation is thus based on the information and videography provided by the distributor, and our knowledge of the product.Results: visual inspection of the provided videography revealed that the manometer pressure was fluctuating.Conclusion: without the subject device being returned for evaluation, the exact cause of the reported event could not be determined.The neopuff is a portable, reusable device that can be susceptible to impact damage, for instance when accidentally dropped orsubjected to considerable external force.The neopuff technical manual warns against dropping the neopuff or subjecting it to impact damage which may cause the unit to operate incorrectly.If the neopuff is suspected to have been damaged, the manometer and valve system should be performance tested.In addition, 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".As mentioned, the neopuff technical manual states the following: - dropping the neopuff / perivent infant resuscitator or other similar forms of impact may cause damage resulting in incorrect operation of the unit.If you suspect damage to have occurred, please perform checks as outlined [in the manual] before connection to a patient.
Event or Problem Description
A distributor in south africa has reported that the manometer spikes when adjusting the maximum pressure relief knob of a rd900aeu neopuff infant resuscitator.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 ; 9494341005
• MDR Report Key: 24676392
• Report Number: 9611451-2026-01052
• Device Sequence Number: 21357623
• Product Code: FMT
• UDI-Device Identifier: 09420012410931
• UDI-Public: (01)09420012410931(10)2103863425(11)250718
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K971695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: 2103863425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown