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

Model Number	RT380
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 china reported on behalf of a healthcare facility that an mr290v vented autofeed humidification chamber provided with an rt380 adult dual heated evaqua2 breathing circuit was found cracked.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Additional Manufacturer Narrative
(b)(6).Correction: section d8: section unticked.Method: the subject mr290v vented autofeed humidification chamber provided with an rt380 adult dual heated evaqua2 breathing circuit, additional information, and photographs were requested to be provided to fisher & paykel (f&p) healthcare in new zealand for evaluation.Results: the subject mr290v vented autofeed humidification chamber was not provided to f&p healthcare for evaluation.Visual inspection of the provided photographs of the subject device observed vertical crack lines on the chamber dome, confirming the reported issue.Conclusion: based on the information provided by the customer 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 to check for any leaks present in the chamber dome due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection 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 mr290v vented autofeed humidification chamber state the following: 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 of the mr290 above maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilator pressure.Use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.Ensure appropriate ventilator or flow source alarms are set before connecting breathing sets to patient.
Event or Problem Description
A distributor in china reported on behalf of a healthcare facility that an mr290v vented autofeed humidification chamber provided with an rt380 adult dual heated evaqua2 breathing circuit was found cracked.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• 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, 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: 24706254
• Report Number: 9611451-2026-01093
• Device Sequence Number: 10439888
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2104031614(11)251010(17)301010
• 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,Followup
• Report Date (Section B): 06/17/2026

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: 2104031614
• 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: 02/28/2026
• Supplement Date Received by Manufacturer: 03/28/2026; 03/28/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/22/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2025
• 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
• Patient Sex: Unknown