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

Model Number	RT329
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher and paykel (f&p) healthcare are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject mr290v autofeed humidification chamber provided as a part of an rt329 infant continuous flow circuit to f&p healthcare new zealand for investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in finland reported that an mr290v autofeed humidification chamber provided as a part of an rt329 infant continuous flow circuit, had a hole on the side of the chamber and was leaking water.There was no patient consequence.
Event or Problem Description
A healthcare facility in finland reported that an mr290v autofeed humidification chamber provided as a part of an rt329 infant continuous flow circuit, had a hole on the side of the chamber and was leaking water.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4) corrections: section b4: field updated to the date of this report.Section d4: serial number intentionally left blank as the information is not applicable.Section d4: incorrect device details were provided in the initial report.Device details were unable to be confirmed by the healthcare facility; thus the field is left blank.Method: the subject mr290v autofeed humidification chamber provided as a part of an rt329 infant continuous flow circuit was requested from the healthcare facility however was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is based on the information, photograph and description of events provided by the healthcare facility, and our knowledge of the product.Results: the healthcare facility stated that the mr290v humidification chamber had a small hole on the side of the chamber and was causing a water leak.There were no patient consequences reported by the healthcare facility.Visual inspection of the provided photograph was unable to confirm the reported issue.No damage to the chamber dome or feedset was visible on the provided photograph.Conclusion: without the return of the subject device, f&p healthcare's investigation was unable to confirm and determine the exact cause of the reported issue.The user instructions provided with the rt329 infant continuous flow circuit include the following: "do not use the chamber if the seals are not intact of if it has been dropped." "visually inspect breathing sets for damage (e.G.A crushed tub 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." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".
Additional Manufacturer Narrative
(b)(4).Corrections: section b4: date of this report updated.Section d4: serial number intentionally left blank as the information is not applicable.Section d4: incorrect device details were provided in the initial report.Device details were unable to be confirmed by the healthcare facility, thus the field is left blank.Section d9: device available for evaluation, returned to manufacturer checked, date returned to manufacturer updated.Section g3: date received by manufacturer updated.Section g6: type of report updated.Section h2: device evaluation updated.Section h3: device evaluated by manufacturer checked.Method: the subject mr290v autofeed humidification chamber provided as a part of an rt329 infant continuous flow circuit was requested from the healthcare facility and was received at fisher & paykel (f&p) healthcare in new zealand for investigation.Our investigation is thus based on the evaluation of the subject device, the information provided by the healthcare facility, and our knowledge of the product.Results: the healthcare facility stated that the mr290v humidification chamber had a small hole on the side of the chamber and was causing a water leak.Visual inspection of the returned mr290v humidification chamber observed that the water feedset tube connecting to the chamber was damaged.There was no hole observed on the chamber dome.Conclusion: f&p healthcare's investigation was unable to determine the exact cause of the reported issue.The user instructions provided with the rt329 infant continuous flow circuit include the following: - "do not use the chamber if the seals are not intact of if it has been dropped." - "visually inspect breathing sets for damage (e.G.A crushed tub 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." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".
Event or Problem Description
A healthcare facility in finland reported that an mr290v autofeed humidification chamber provided as a part of an rt329 infant continuous flow circuit, had a hole on the side of the chamber and was leaking water.There was no patient consequence.

• 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: 22672589
• Report Number: 9611451-2025-00719
• Device Sequence Number: 3716816
• Product Code: BTT
• UDI-Device Identifier: 09420012431073
• UDI-Public: (01)09420012431073(10)2102708371(11)230726(17)280726
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K020332
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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: RT329
• Device Catalogue Number: RT329
• Device Lot Number: 2102708371
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 02/12/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/29/2025; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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