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

Model Number	RT380
Medical Device Problem Codes	Mechanical Problem (1384); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The subject rt380 breathing circuit has been requested to be returned to fisher & paykel healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in italy reported that an rt380 adult dual heated evaqua2 breathing circuit failed the ventilator leak test prior to patient use.The healthcare facility further reported that the expiratory tubing is damaged.There was no patient involvement.
Event or Problem Description
A healthcare facility in italy reported that an rt380 adult dual heated evaqua2 breathing circuit failed the ventilator leak test prior to patient use.The healthcare facility further reported that the expiratory tubing is damaged.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Correction: section d1: brand name updated.Section h11: method: the subject rt380 adult dual heated evaqua2 breathing circuit was received at fisher & paykel healthcare in new zealand for evaluation, where it was visually inspected and analysed.Our investigation is based on the evaluation of the subject device, the information provided by the healthcare facility and our knowledge of the product.Results: visual inspection of the returned device identified a cut on the expiratory limb of the subject rt380 adult dual heated evaqua2 breathing circuit.Further analysis confirmed the presence of a leak.Conclusion: the reported leak and damage was confirmed, and was most likely caused by a sharp object.All rt380 breathing circuits are visually inspected, and pressure and flow tested during production and those that fail are rejected.The subject circuit would have met the required specifications at the time of production.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.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.- visually inspect breathing sets for damage (e.G.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: 24126506
• Report Number: 9611451-2026-00303
• Device Sequence Number: 5891118
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2103845749(11)250704(17)300704
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 2103845749
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2025
• 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