MAUDE Adverse Event Report: FISHER & PAYKEL HEALTCARE LTD F&P EVAQUA 2; BREATHING CIRCUIT

Model Number	RT380
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method:the subject mr290v autofeed humidification chamber provided as part of the rt380 adult dual heated evaqua2 breathing circuit and additional information, were requested to be provided to fisher & paykel (f&p) healthcare for evaluation.Results: there was no response to f&p healthcare's requests for additional information and return of the subject device.Conclusion: based on the limited information provided by the user and without the return of the subject device, we are unable to confirm or determine the cause of the reported issue.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 following 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 rt380 adult dual heated evaqua2 breathing circuit state the following: - perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.- ensure appropriate ventilator or flow source alarms are set before connecting breathing sets to patient.- visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.- do not soak, wash, or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.- use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.
Event or Problem Description
A healthcare facility in china reported via a distributor that an mr290v vented autofeed humidification chamber provided as part of the rt380 adult dual heated evaqua2 breathing circuit was found leaking water during use.There was no reported patient consequence.

• Brand Name: F&P EVAQUA 2
• Common Device Name: BREATHING CIRCUIT
• Manufacturer (Section D): FISHER & PAYKEL HEALTCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurce 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: 24867651
• Report Number: 9611451-2026-01269
• Device Sequence Number: 9100413
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2103915346(11)250820(17)300820
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 2103915346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown