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

Model Number	RT380
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Fisher & paykel (f&p) healthcare is currently 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 reported on behalf of a healthcare facility in china that an mr290v vented autofeed humidification chamber provided with an rt380 adult dual heated evaqua2 breathing circuit was found leaking water from cracks on the chamber dome after 6 days of use.There was no reported patient harm.
Additional Manufacturer Narrative
(b)(4).Correction: section d2b: corrected fda product code.Section h11: method: the subject mr290v vented autofeed humidification chamber provided with an rt380 adult dual heated evaqua2 breathing circuit was not available to be returned to f&p healthcare for evaluation as the device had been discarded by the healthcare facility.Our evaluation is therefore based on the information, photographs, and video provided by the healthcare facility, and our knowledge of the product.Results: a review of a provided photographs and video confirmed the presence of a crack on the dome of the chamber.Conclusion: based on the information provided by the healthcare facility and without the return of the device, we are unable to determine the cause of the crack.As part of design validation and verification activities, all f&p healthcare products are tested to ensure they meet documented product requirements and specifications.These requirements and specifications encompass user needs, performance requirements, international product standards as well as quality system requirements.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 and breathing circuit kit would have met the required specification at the time of production.The user instructions for the rt380 adult dual heated evaqua2 breathing circuit state the following: - do not use the chamber if the seals are not intact when received, or if it has been dropped.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.- 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 set to patient.- ensure there is a water supply connected to the chamber and that water is present within the chamber.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that an mr290v vented autofeed humidification chamber provided with an rt380 adult dual heated evaqua2 breathing circuit was found leaking water from cracks on the chamber dome after 6 days of use.There was no reported patient harm.

• 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: 24242872
• Report Number: 9611451-2026-00423
• Device Sequence Number: 8309889
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2103913878(11)250819(17)300819
• 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): 03/06/2026

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: 2103913878
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/08/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER; F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER
• Patient Sex: Unknown