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	11/01/2024
Type of Reportable Event	Malfunction
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.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The subject rt266 breathing circuit is currently en route to nz for evaluation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the subject rt266 breathing circuit was received at fisher & paykel (f&p) healthcare in new zealand for evaluation, where it was visually inspected and analysed.Results: visual inspection of the tubing did not identify any visible deformities; however, leak testing confirmed the presence of leaks from micro voids in the tubing.Conclusion: the reported leak was confirmed.All rt266 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 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 (e.G.A crushed tube or cracked connector) before use and replace if damaged.
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.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: 20803079
• Report Number: 9611451-2024-00878
• Device Sequence Number: 9934980
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2103089408(11)240416(17)290416
• 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): 11/01/2024

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: 2103089408
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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