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	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject mr290v vented autofeed humidification chamber provided with an rt202 adult breathing circuit 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 healthcare facility in canada reported via a fisher & paykel (f&p) healthcare field representative that an mr290v vented autofeed humidification chamber provided with an rt202 adult breathing circuit was found leaking water after 6 days of patient use.There was no reported patient harm.
Event or Problem Description
A healthcare facility in canada reported via a fisher & paykel (f&p) healthcare field representative that an mr290v vented autofeed humidification chamber provided with an rt202 adult breathing circuit was found leaking water after 6 days of patient use.There was no reported patient harm.
Additional Manufacturer Narrative
(b)(6).Method: the subject mr290v vented autofeed humidification chamber provided with the rt202 adult breathing circuit was returned to fisher & paykel (f&p) healthcare in new zealand, where it was visually inspected and analysed.Results: visual inspection of the returned mr290v vented autofeed humidification chamber confirmed the presence of a crack along the base of the chamber dome.Leak testing confirmed the presence of a leak.Further analysis identified evidence that the chamber had been exposed to significant amounts of an incompatible chemical.Conclusion: the reported water leakage was confirmed and was caused by a crack on the chamber's dome.Based on our investigation, the crack was likely to be caused by exposure to an incompatible chemical, resulting in environmental stress cracking of the chamber dome.Every mr290v vented autofeed humidification chamber is pressure tested following the manufacturing process and any holes, cracks, or leaks would be identified during this process.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails these tests is rejected.The subject mr290v vented autofeed humidification chamber would have met the required specifications at the time of production.The user instructions for the rt202 adult breathing circuit state the following: - do not soak, wash, or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.- use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.- ensure appropriate ventilator or flow source alarms are set before connecting breathing sets to patient.- visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damage - do not use the chamber if the seals are not intact when received, or if it has been dropped.

• 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: 24110621
• Report Number: 9611451-2026-00210
• Device Sequence Number: 17506923
• Product Code: BTT
• UDI-Device Identifier: 09420012430304
• UDI-Public: (01)09420012430304(10)2103967291(11)250922(17)300922
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 2103967291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AEROGEN NEBULIZER; AEROGEN NEBULIZER; TEMPERATURE PROBES (BRAND + MODEL NOT PROVIDED); TEMPERATURE PROBES (BRAND + MODEL NOT PROVIDED); TRILOGY VENTILATOR; TRILOGY VENTILATOR
• Patient Sex: Unknown