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)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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.
Event or Problem Description
A distributor in colombia reported via a fisher & paykel (f&p) healthcare field representative, that an rt330 optiflow tubing kit generated a leak alarm.There were no reported patient consequences.
Event or Problem Description
A distributor in colombia reported via a fisher & paykel (f&p) healthcare field representative, that an rt330 optiflow tubing kit generated a leak alarm.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Corrections: section b4: updated to reflect date of this report.Method: the subject rt330 infant optiflow circuit was not returned to fisher & paykel (f&p) healthcare for evaluation.F&p healthcare requested for further information from the distributor, including the sequence of events, photographs, diagrams of the device set-up etc.However, no photographs and limited information was provided.Our investigation is based on the information provided by the distributor and our knowledge of the product.Results: the customer reported that the rt330 infant optiflow circuit generated an air leak alarm.Conclusion: without the subject device, we are unable to confirm the reported malfunction.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.".

• 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: 22651968
• Report Number: 9611451-2025-00711
• Device Sequence Number: 18312193
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2102674512(11)230630(17)280630
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 2102674512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/03/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• 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