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	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Section h11: the subject rt205 adult ventilator circuit and additional information 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 japan, via a fisher & paykel (f&p) healthcare field representative, that multiple rt205 adult ventilator circuits failed the pre-use ventilator leak test prior to patient use.There was no reported patient harm.
Additional Manufacturer Narrative
(b)(4).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.Section h11: method: six rt205 adult ventilator circuits were returned to fisher & paykel (f&p) healthcare in new zealand for evaluation, where they were visually inspected and leak tested.Results: visual inspection of the returned devices identified no damage to any part of the breathing circuits.Leak testing confirmed the reported leaks for four of the returned devices.Further investigation identified that the leaks were coming through a buldge in the bowl of the water trap, affecting the seal between the lid and the bowl.Conclusion: the reported leaks were confirmed and may have been due to misassembly, leading to the water trap bowl not fully engaging with the lid.The water trap of the breathing circuit consists of two parts, a lid and a bowl, which can be separated to allow the user to empty the water trap.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 reported on behalf of a healthcare facility in japan, via a fisher & paykel (f&p) healthcare field representative, that multiple rt205 adult ventilator circuits failed the pre-use ventilator leak test prior to patient use.There was no reported patient harm.

• 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: 22778868
• Report Number: 9611451-2025-00736
• Device Sequence Number: 9342211
• Product Code: BZE
• UDI-Device Identifier: 09420012430410
• UDI-Public: (01)09420012430410(10)2103442162(11)241030(17)291030
• 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): 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): 10/28/2025

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: 2103442162
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 10/12/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P HEALTHCARE MR850GJU RESPIRATORY HUMIDIFIER; F&P HEALTHCARE MR850GJU RESPIRATORY HUMIDIFIER; PURITAN BENNETT 980 VENTILATOR; PURITAN BENNETT 980 VENTILATOR
• Patient Sex: Unknown