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

Model Number	RT266
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)(6).The rt266 infant dual-heated evaqua2 breathing circuit has been requested to be returned to fisher & paykel (f&p) 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 (b)(6), that tubing of an rt266 infant dual heated evaqua2 breathing circuit was found broken during patient use.There was no reported patient harm.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in colorado, that the tubing of an rt266 infant dual heated evaqua2 breathing circuit was found leaking during patient use.Following inspection by the healthcare facility, damage was identified.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(6).Corrections: section d1: brand name updated.Section d4: udi updated.Section e4: updated to 'yes'.Related report number added to section h10.Section h5: updated to 'yes'.Section h11: method: the inspiratory limb of the subject rt266 infant dual heated evaqua2 breathing circuit was received at fisher & paykel (f&p) healthcare in new zealand for investigation, where it was visually inspected and leak tested.Results: visual inspection identified no damage or defects with the returned inspiratory limb.Leak testing confirmed that the inspiratory limb was within specification.Conclusion: based on the information provided by the customer and without the return of the complete subject device, we are unable to confirm or 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 breathing circuit would have met the required specificatios at the time of production.The user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: - visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.- check all connections are tight before use.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- ensure appropriate ventilator and flow source alarms are set before connecting breathing set to patient.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.

• 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: 23610580
• Report Number: 9611451-2025-01597
• Device Sequence Number: 9805458
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2103909444(11)250819(17)300819
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K103767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 2103909444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White