MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; BREATHING CIRCUIT

Model Number	RT265
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject rt265 infant dual-heated evaqua2 breathing circuit has been requested to be returned to fisher & paykel (f&p) healthcare 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, via a fisher & paykel (f&p) healthcare field representative, that an rt265 infant dual-heated evaqua2 breathing circuit failed the ventilator leak test prior to patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the subject rt265 infant dual-heated evaqua2 breathing circuit was received at fisher & paykel (f&p) healthcare in new zealand for evaluation, where it was visually inspected and leak tested.Results: visual inspection found no physical damage to the breathing circuit.Leak testing confirmed the presence of a leak.Further inspection of the device identified a deformity on the duckbill slit, which was determined to be the source of the leak.Conclusion: the reported leak was confirmed and was due to a deformity in the duckbill slit on the swivel connector of the circuit.The user instructions that accompany the rt265 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.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 japan, via a fisher & paykel (f&p) healthcare field representative, that an rt265 infant dual-heated evaqua2 breathing circuit failed the ventilator leak test prior to patient use.There was no patient involvement.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• 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: 23034312
• Report Number: 9611451-2025-00876
• Device Sequence Number: 21253309
• Product Code: BZE
• UDI-Device Identifier: 09420012430205
• UDI-Public: (01)09420012430205(10)2103607358(11)250204(17)300204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Device Lot Number: 2103607358
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER.; F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER.; PURITAN BENNETT 980 VENTILATOR.; PURITAN BENNETT 980 VENTILATOR.
• Patient Sex: Unknown