MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; NEOPUFF INFANT RESUSCITATOR

Model Number	RD900AFU
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 healthcare facility in france has reported that a rd900afu neopuff infant resuscitator does not retain the settings during use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(6).Method: the subject device, rd900aeu neopuff infant resuscitator was returned to our fisher & paykel healthcare (f&p) service center in france where it was inspected by a trained f&p service technician.Our investigation is thus based on the information provided by the f&p service technician, the information provided by the healthcare facility and our knowledge of the product.The service center also reported that the device was returned to the customer.Results: the subject device was performance tested by a f&p service technician.The subject device has passed the performance testing and the f&p service technician could not replicate the reported event.No fault could be identified with the subject device.Conclusion: we could not confirm and determine the cause of the reported event.As part of our manufacturing process, each neopuff unit undergoes 100% testing on the production line to ensure compliance with critical product specifications.Units that do not meet the specifications are rejected.
Event or Problem Description
A healthcare facility in france has reported that a rd900afu neopuff infant resuscitator does not retain the settings during use.There was no reported patient consequence.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• 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: 23373013
• Report Number: 9611451-2025-01111
• Device Sequence Number: 15940208
• Product Code: FMT
• UDI-Device Identifier: 09420012410948
• UDI-Public: (01)09420012410948(10)2100550805(11)180806
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: RD900AFU
• Device Catalogue Number: RD900AFU
• Device Lot Number: 2100550805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/16/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2018
• 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