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

Model Number	RT380
Medical Device Problem Codes	Crack (1135); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject rt380 adult dual heated evaqua2 breathing circuit has been requested to be returned to fisher & paykel healthcare in new zealand for evaluation.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 japan that an rt380 adult dual heated evaqua2 breathing circuit failed the pre-use ventilator leak test during setup and prior to patient use.There was no patient involvement.

• 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: 24341695
• Report Number: 9611451-2026-00542
• Device Sequence Number: 13146967
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2103816432(11)250620(17)300620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2026

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: 2103816432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 02/15/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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: DRAGER EVITA V300 VENTILATOR; F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER
• Patient Sex: Unknown