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

Model Number	RT205
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in japan reported on behalf of a healthcare facility that the rt205 adult ventilator circuit was leaking during patient use.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel (f&p) healthcare are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject rt205 adult ventilator circuit to f&p healthcare new zealand for investigation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(6).Corrections: section g4: the rt205 adult ventilator circuit is not sold in the usa but is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Method: the subject rt205 adult ventilator circuit was received at fisher & paykel (f&p) healthcare in new zealand for investigation, where it was visually inspected.Our investigation is thus based on the evaluation of the subject device, the information provided by the healthcare facility and our knowledge of the product.Results: visual inspection of the subject rt205 adult ventilator circuit observed no notable damage to the returned device.The subject device was tested, and confirmed that the subject device was within gas leakage specifications.Conclusion: we are unable to determine what may have caused the reported failed ventilator leak test, as there was no fault found with the returned device.All rt205 adult ventilator circuits are visually inspected, as well as pressure and flow tested during production, and those that fail the test are rejected.The rt205 adult ventilator circuit would have met the required specifications at the time of production.The user instructions for the rt205 adult ventilator circuit states the following: - check all connections are tight before use.- visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.- 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.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.
Event or Problem Description
A distributor in japan reported on behalf of a healthcare facility that the rt205 adult ventilator circuit was leaking during patient use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• 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: 22959683
• Report Number: 9611451-2025-00846
• Device Sequence Number: 13170923
• Product Code: BZE
• UDI-Device Identifier: 09420012430410
• UDI-Public: (01)09420012430410(10)2103597336(11)250129(17)300129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2025

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: RT205
• Device Catalogue Number: RT205
• Device Lot Number: 2103597336
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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