MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; 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	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in china reported that an mr290v vented autofeed humidification chamber provided with an rt380 adult dual heated evaqua2 breathing circuit was found leaking water.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(6).Method: the subject mr290v autofeed humidification chamber provided as part of the rt380 adult dual heated evaqua2 breathing circuit, additional information, and photographs were requested to be provided to f&p healthcare for analysis.Results: there was no response to f&p healthcare's requests for additional information, photographs, 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.

• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine 92618 ; 9494341005
• MDR Report Key: 24602111
• Report Number: 9611451-2026-00775
• Device Sequence Number: 18238839
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2103894299(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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 2103894299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 03/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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