MAUDE Adverse Event Report: Fisher & Paykel Healthcare Ltd F&P Neopuff; INFANT RESUSCITATOR

Model Number	RD900AEU
Medical Device Problem Codes	Pressure Problem (3012); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in south africa reported that the maximum pressure relief knob and the peak inspiratory pressure knob of an rd900aeu neopuff infant resuscitator are not rotating smoothly.It was further reported that 12 other units were affected.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Section d4: additional udi details for the rd900aeu neopuff infant resuscitator: (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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; +1(949)434-1005
• MDR Report Key: 24880484
• Report Number: 9611451-2026-01313
• Device Sequence Number: 10460100
• Product Code: FMT
• UDI-Device Identifier: 09420012410931
• UDI-Public: (01)09420012410931(10)2104163718(11)260128
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 2104163718
• Was Device Available for Evaluation?: No
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• 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