MAUDE Adverse Event Report: Fisher & Paykel Healthcare Ltd F&P Neopuff; 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)
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in south africa reported that the peak inspiratory pressure knob and or the max pressure relief knob of four rd900aeu neopuff infant resuscitator was not rotating smoothly during acceptance checks.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the subject devices, rd900aeu neopuff infant resuscitators was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and videography provided by the distributor, and our knowledge of the product.Results: evaluation of the the provided videography has revealed that the peak inspiratory pressure and or maximum pressure relief knobs were having some resistance when adjusting the pressure.Conclusion: based on previous investigations, the most likely cause to the reported fault is that the valve thread start position knocks the thread stop one revolution before its intended rotation, resulting in some resistance at the low pressure settings, as described by the distributor.The reported resistance is only observed at the extreme counterclockwise end of valve travel, corresponding to the 0 to 5 cmh2o range.Within this operating range, the pip valve is not intended to control therapy pressure, as pressure is instead set by the user through the peep adjustment on the breathing circuit.The technical manual specifies that neopuff manometer reading should be checked to be zero with no flow connected, and that the valve testing should be conducted at set pressures between 10 and 40 cmh2o.While the physical characteristic observed during adjustment may be noticeable to the user, it is concluded that it does not affect compliance with the functional performance requirements of the product.

• 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: 50704330
• Report Number: 9611451-2026-02663
• Device Sequence Number: 20312182
• Product Code: FMT
• UDI-Device Identifier: 09420012410931
• UDI-Public: (01)09420012410931(10)2104405797(11)260615
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 2104405797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown