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

Model Number	RT225
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel (f&p) healthcare is currently in the process of finalizing the investigation.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 china that two mr290v autofeed humidification chambers, provided as a part of an rt225 infant ventilator circuit single heated with mr290 autofeed chamber, were found cracked.There was no patient harm reported.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chambers provided with the rt225 infant breathing circuit kit were unable to be returned to f&p healthcare for evaluation as they had been discarded by the healthcare facility.Our investigation is therefore based on the information and photographs provided, and our knowledge of the product.Results: visual inspection of the provided photographs confirmed the presence of a crack on the dome of a chamber.Conclusion: based on the information provided by the healthcare facility and without the return of the subject devices, we are unable to determine the cause of the reported issue.As part of design validation and verification activities, all f&p healthcare products are tested to ensure they meet documented product requirements and specifications.These requirements and specifications encompass user needs, performance requirements, international product standards as well as quality system requirements.All mr290v vented autofeed humidification chambers are visually inspected during the manufacturing process.Additionally, every mr290v vented autofeed humidification chamber is leak tested at the completion of the assembly process.Any chamber which fails these tests is rejected.The subject mr290v vented autofeed humidification chambers would have met the required specification at the time of production.The user instructions that accompany the rt225 infant breathing circuit state the following: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Do not use the chamber if the seals are not intact when received, or if it has been dropped.Ensure there is a water supply connected to the chamber and that water is present within the chamber.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 damaged.Do not soak, wash, sterilize, or reuse 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.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that two mr290v autofeed humidification chambers, provided as a part of rt225 infant breathing circuits, were found cracked.There was no patient harm reported.

• 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: 24110484
• Report Number: 9611451-2026-00243
• Device Sequence Number: 10344176
• Product Code: BZE
• UDI-Device Identifier: 09420012431080
• UDI-Public: (01)09420012431080(10)2103500837(11)241127(17)291127
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: RT225
• Device Catalogue Number: RT225
• Device Lot Number: 2103500837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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
• Patient Sex: Unknown