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

Model Number	RT330
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility reported via a fisher & paykel (f&p) healthcare field representative in taiwan reported that an rt330 optiflow tubing kit was leaking.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel (f&p) healthcare is in the process of completing our investigation.We will provide a follow-up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the subject rt330 optiflow tubing kit was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is based on the information, photograph and description of events provided by the healthcare facility, previous investigations of similar complaints and our knowledge of the product.Results: the healthcare facility reported that the rt330 optiflow tubing kit was leaking near the chamber elbow.Visual inspection of the provided photograph was unable to confirm the reported issue.Conclusion: without the subject device, we are unable to determine the exact cause of the reported fault.All rt330 optiflow junior tubing kits including the pressure relief valve are pressure and leak tested prior to being released for distribution.The pressure and leak test is followed by a visual inspection of the devices.Any circuits or pressure relief valves that fail are rejected.The user instructions that accompany the rt330 infant optiflow circuit states: - "do not use beyond 7 days maximum duration of use." - "do not soak, wash or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "do not use an in-line nebulizer between the pressure relief valve manifold and the dry side of the humidification chamber." - "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times." - "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use, and replace if damaged." - "discard product if the pressure relief valve is damaged or damage is suspected.".
Event or Problem Description
A healthcare facility in taiwan reported via a fisher & paykel (f&p) healthcare field representative, that an rt330 optiflow tubing kit was found leaking.There was no reported patient involvement.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BREATHING 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 23164011
• Report Number: 9611451-2025-00961
• Device Sequence Number: 8883024
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2103701820(11)250331(17)300331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2103701820
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/28/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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