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

Model Number	RT380
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in china reported via a fisher & paykel (f&p) healthcare field representative that the rt380 adult dual heated evaqua2 breathing circuit failed the pre-use leak test.There was no patient involvement.
Additional Manufacturer Narrative
(b)(6).Method: the subject 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 rt380 adult dual heated evaqua2 breathing circuit was not provided to f&p healthcare for evaluation as it was confirmed to be discarded.Visual inspection of the provided photographs of the subject rt380 adult dual heated evaqua2 breathing circuit, observed a hole in the inspiratory, confirming the reported issue.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.All rt380 adult dual heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production and those that fail are rejected.The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit state: - perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- visually inspect breathing sets for damage (e.G.A 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, 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: 25436643
• Report Number: 9611451-2026-01814
• Device Sequence Number: 10335246
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2104052721(11)251111(17)301111
• 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): 06/08/2026

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: 2104052721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2025
• 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