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

Model Number	RT266
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject rt266 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 distributor reported on behalf of a healthcare facility in japan that an rt266 infant dual-heated evaqua2 breathing circuit failed the ventilator leak test prior to patient use.The healthcare facility identified a leak from the expiratory tube.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4) method: the subject rt266 infant ventilator circuit was received at fisher & paykel healthcare (f&p) in new zealand for evaluation.Results: visual inspection found no visible damage to the returned breathing circuit.However, leak testing confirmed a leakage at the connection between the elbow connector and the collar of the expiratory tube.Conclusion: the reported leak was confirmed and was due to a defect at the connection between the elbow and the collar of the expiratory tube.All rt266 infant ventilator circuits are visually inspected, and pressure and flow tested during production.Those that fail are rejected.The user instructions that accompany the rt266 infant ventilator circuit also state the following: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Check all connections are tight before use.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to the patient.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that an rt266 infant dual-heated evaqua2 breathing circuit failed the ventilator leak test prior to patient use.The healthcare facility identified a leak from the expiratory tube.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: 21674660
• Report Number: 9611451-2025-00253
• Device Sequence Number: 12814666
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2102906841(11)231201(17)281201
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2102906841
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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; PURITAN BENNETT 980
• Patient Sex: Unknown