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

Model Number	RT266
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject rt266 infant 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 china via a fisher & paykel (f&p) healthcare field representative, that the inspiratory tubing of an rt266 infant dual heated evaqua2 breathing circuit was found with a crack prior to patient use.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(6).Correction: section d1: brand name has been updated.Section h11: the subject rt266 infant dual heated evaqua2 breathing circuit, was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is based on the photographs and description of events provided by the customer and our knowledge of the product.Results: review of the provided photograph observed that the inspiratory tube of the rt266 infant dual heated evaqua2 breathing circuit had a small hole near the patient end connector, confirming the reported issue.Conclusion: based on the information provided by the customer and without the return of the subject device, we are unable to determine the exact cause of the reported fault.All rt266 infant dual heated evaqua2 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 rt266 infant 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 before use and replace if damaged.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china via a fisher & paykel (f&p) healthcare field representative, that the inspiratory tubing of an rt266 infant dual heated evaqua2 breathing circuit was found with a crack prior to patient use.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: 24449612
• Report Number: 9611451-2026-00614
• Device Sequence Number: 18634254
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2103790398(11)250527(17)300527
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2103790398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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