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

Model Number	RT202
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The subject mr290v vented autofeed humidification chamber 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 in japan reported on behalf of a healthcare facility that an mr290v vented autofeed humidification chamber, provided as a part of an rt202 adult breathing circuit, was found cracked and leaking water from the bottom of the chamber during patient use.There was no reported patient consequence.
Event or Problem Description
A distributor in japan reported on behalf of a healthcare facility that an mr290v vented autofeed humidification chamber, provided as a part of an rt202 adult breathing circuit, was found cracked and leaking water from the bottom of the chamber during patient use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: only the mr290v vented autofeed humidification chamber, which is part of the subject rt202 breathing circuit was returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.Results: visual inspection of the returned mr290v vented autofeed chamber identified a crack along the chamber base.Additional analysis identified evidence that the chamber had been subjected to an excessive stress resulting with stress cracks forming over time.Conclusion: the reported leak was likely due to an excessive stress causing a crack along the mr290v humidification chamber base.The cause of the stress was not determined.The mr290v vented autofeed humidification chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.All mr290v vented autofeed humidification chambers and rt202 breathing circuits are pressure and flow tested during production, and those that fail are rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject breathing circuit kit would have met the required specifications at the time of production.The user instructions that accompany the rt202 breathing circuit state the following: - ensure appropriate ventilator and flow source alarms are set before connecting breathing set to patient.- 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.- use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.- do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.

• 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: 20972799
• Report Number: 9611451-2024-00982
• Device Sequence Number: 4195659
• Product Code: BTT
• UDI-Device Identifier: 09420012430304
• UDI-Public: (01)09420012430304(10)2103177108(11)240614(17)290614
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983112
• 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): 12/02/2024

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: RT202
• Device Catalogue Number: RT202
• Device Lot Number: 2103177108
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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 MR850 RESPIRATORY HUMIDIFIER; F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER; OXYGEN BLENDER OA2060; OXYGEN BLENDER OA2060
• Patient Sex: Unknown