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

Model Number	RT330
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The subject mr290v vented autofeed humidification chamber has been requested to be returned to fisher & paykel healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor in colombia reported that an mr290v vented autofeed humidification chamber, provided as a part of an rt330 optiflow tubing kit, was leaking water during patient use.There was no reported patient consequence.
Event or Problem Description
A distributor in colombia reported that an mr290v vented autofeed humidification chamber, provided as a part of an rt330 optiflow tubing kit, was leaking water during patient use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chamber provided with the rt330 optiflow tubing kit was not returned to fisher & paykel (f&p) healthcare in new zealand.Results: review of the provided video confirmed that the subject humidification chamber was leaking water between the chamber base and chamber dome.Conclusion: the reported damage was confirmed by reviewing the provided video.Without the return of he subject device, we are unable to confirm the cause of the observed water leak.Every mr290v vented autofeed humidification chamber is pressure tested following the manufacturing process and any holes, cracks, or leaks would be identified during this process.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails these tests is rejected.The subject mr290v vented autofeed humidification chamber would have met the required specifications at the time of production.The user instructions for the rt330 optiflow tubing kit state the following: - use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.- the use of breathing circuits, chambers, accessories, or combinations which are not approved by fisher & paykel healthcare may result in poor humidification system performance, ventilator malfunction and harm to the patient/user.- do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- ensure there is a water supply connected to the chamber and that water is present within the chamber.

• 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: 22683611
• Report Number: 9611451-2025-00720
• Device Sequence Number: 8936830
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/23/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown