MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE 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	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel (f&p) healthcare is currently in the process of completing our evaluation.A follow up report will be provided upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china, that the mr290v vented autofeed humidification chamber provided with an rt380 adult dual heated evaqua2 breathing circuit was found leaking water from the chamber base after one day of patient use.There were no reported patient consequences.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china, that the mr290v vented autofeed humidification chamber provided with an rt380 adult dual heated evaqua2 breathing circuit was found leaking water from the chamber base after one day of patient use.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(6).Method: the subject mr290v vented autofeed humidification chamber provided with the rt380 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel (f&p) healthcare as it had been discarded by the healthcare facility.Additional information and photographs were requested to be provided to f&p healthcare in new zealand for evaluation.Results: visual inspection of the provided photographs and video of the subject mr290v vented autofeed humidification chamber confirmed the reported leak.Conclusion: based on the information provided by the healthcare facility and without the return of the subject device, f&p healthcare's investigation was unable to 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 followed by a visual inspection of each chamber.Any chamber which fails these tests is rejected.The subject mr290v vented autofeed humidification chamber and breathing circuit kit 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.- do not soak, wash or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.- do not use the chamber if the seals are not intact when received, or if it has been dropped.- use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.- ensure there is a water supply connected to the chamber and that water is present within the chamber.- 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.

• Brand Name: F&P EVAQUA 2
• Common Device Name: BREATHING CIRCUIT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 25038212
• Report Number: 9611451-2026-01460
• Device Sequence Number: 9580273
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2103894788(11)250805(17)300805
• 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,Followup
• Report Date (Section B): 05/26/2026

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: 2103894788
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER
• Patient Sex: Unknown