MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; RESUSCITATION CIRCUIT

Model Number	RD1300-10
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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 distributor in colombia reported via a fisher & paykel healthcare (f&p) field representative that the peep valve of the rd1300-10 neopuff t-piece circuit was not moving.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(6).Method: the subject device, rd1300-10 neopuff t-piece circuit 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 distributor, and our knowledge of the product.Results: visual inspection of the subject device has revealed that the threads on the positive end-expiratory pressure port adaptor was deformed causing the adaptor cap (t-piece cap) to not rotate as intended.Conclusion: we are unable to confirm the cause of the reported event.The rd1300-10 neopuff t-piece circuit is a single use breathing circuit intended to provide ventilatory support to neonates and infants with respiratory insufficiency.The device is designed to connect to the f&p neopuff t-piece resuscitator or any other gas-powered resuscitator compliant to (b)(4).
Event or Problem Description
A distributor in colombia reported via a fisher & paykel healthcare (f&p) field representative that the peep valve of the rd1300-10 neopuff t-piece circuit was not moving.There was no reported patient involvement.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: RESUSCITATION CIRCUIT
• 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: 23373014
• Report Number: 9611451-2025-01102
• Device Sequence Number: 9950380
• Product Code: BTL
• UDI-Device Identifier: 09420012429988
• UDI-Public: (01)09420012429988(10)2103517646(11)241205(17)271205
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K892885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: RD1300-10
• Device Catalogue Number: RD1300-10
• Device Lot Number: 2103517646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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