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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Section d4: lot number, expiration date, udi details of two units were not received from the customer section h4: device manufacturing details of two units were not received from the customer method: the subject devices, three units of rd1300-10 neopuff t-piece circuits were discarded and not returned to fisher & paykel healthcare (f&p), new zealand for evaluation.Our investigation is thus based on the information and description of events provided by the healthcare facility, and our knowledge of the product.Results: the healthcare facility reported that, it was hard to turn or adjust the peep valve of three of the rd1300-10 neopuff t-piece circuits.Conclusion: without the return of the subject devices, we are unable to determine the exact 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).The user instructions that accompany the rd1300 neopuff t-piece circuit state the following: -"ensure pressures are monitored throughout resuscitation." -" test resuscitator function with the blue cap in place or after connecting the test lung to the t-piece circuit.Test before usin.
Event or Problem Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that it was hard to turn or adjust the peep valve of three of the rd1300-10 neopuff t-piece circuits.The healthcare facility further reported that the rd1300-10 neopuff t-piece circuits were discarded and are not available for evaluation.There were no reported patient consequences.

• 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: 22033310
• Report Number: 9611451-2025-00440
• Device Sequence Number: 8733589
• Product Code: BTL
• UDI-Device Identifier: 09420012429988
• UDI-Public: (01)09420012429988(10)2103512748(11)241203
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/16/2025

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: RD1300-10
• Device Catalogue Number: RD1300-10
• Device Lot Number: 2103512748
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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