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

Model Number	RT330
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The subject mr290v vented autofeed humidification chamber provided with the rt330 optiflow tubing kit 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 healthcare facility in the netherlands reported that an mr290v autofeed humidification chamber provided as a part of an rt330 optiflow tubing kit was leaking water.There was no patient harm reported.
Event or Problem Description
A healthcare facility in the netherlands reported that an mr290v autofeed humidification chamber provided as a part of an rt330 optiflow tubing kit was leaking water.There was no patient harm reported.
Additional Manufacturer Narrative
(b)(4).Section h11: method: the subject mr290v vented autofeed humidification chamber provided as a part of an rt330 optiflow tubing kit was returned to fisher & paykel (f&p) healthcare in new zealand for evaluation, where it was visually inspected and analysed.Results: visual inspection of the returned mr290v vented autofeed chamber identified a crack along the base of the dome of the chamber.Further analysis indicated that the crack was most likely due to a mechanical force.Conclusion: the reported leak was confirmed and found to be due to a crack that was observed on the chamber dome.Our investigation was unable to conclusively determine the root cause of the observed crack.Every mr290v vented autofeed humidification chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.Any chamber which fails this test is 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 user instructions for the rt330 optiflow tubing kit state the following: - use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.- the use of breathing circuits, chambers, accessories, or combinations which are not approved by fisher & paykel healthcare may result in poor humidification system performance, ventilator malfunction and harm to the patient/user.- do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- ensure there is a water supply connected to the chamber and that water is present within the chamber.

• 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: 23106371
• Report Number: 9611451-2025-00915
• Device Sequence Number: 15910861
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2103082094(11)240411(17)290411
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2103082094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/21/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown