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	08/21/2025
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.Fisher & paykel (f&p) healthcare is in the process of completing our investigation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A distributor in japan reported on behalf of a healthcare facility that six rt205 adult ventilator circuits were leaking before patient use.There was no patient involvement as the issue was found whilst the devices were not in use on a patient.
Event or Problem Description
A distributor in japan reported on behalf of a healthcare facility that six rt205 adult ventilator circuits were leaking before patient use.There was no patient involvement as the issue was found whilst the devices were not in use on a patient.
Additional Manufacturer Narrative
(b)(4).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.Device 1 batch number 2103604704 packaging bag opened device 2 batch number 2103604704 packaging bag opened device 3 batch number 2103604704 packaging bag sealed device 4 batch number 2103604704 packaging bag sealed device 5 batch number 2103604704 packaging bag sealed method: five of the six reported rt205 adult ventilator circuit kits were received by fisher & paykel healthcare in new zealand for investigation.Each device underwent visual inspection.Our investigation is thus based on the evaluation of the subject devices, the information provided by the customer and our knowledge of the product.Results: visual inspection of the subject devices observed no notable damages to the returned circuits.Leak testing was conducted, with device 1 and device 2 failing the test, while devices 3 to 5 were found to be within leak specification.Further examination of devices 1 and 2 identified that the water trap bowl was not fully engaged with the water trap top.The bowl appeared to be bulging outward around the locking surface.Conclusion: our investigation was unable to identify the exact cause of the observed damage to the rt205 adult ventilator circuit kits.However, based on our product knowledge, the issue is most likely attributable to a manufacturing-related factor.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.

• 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: 23069871
• Report Number: 9611451-2025-00904
• Device Sequence Number: 4786333
• Product Code: BZE
• UDI-Device Identifier: 09420012430410
• UDI-Public: (01)09420012430410(10)2103604704(11)250203(17)300203
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 2103604704
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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: MEDTRONIC PB80 VENTILATOR; MEDTRONIC PB80 VENTILATOR
• Patient Sex: Unknown