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

Model Number	RT266
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2025
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 reported on behalf of a healthcare facility in china that an mr290v autofeed humidification chamber, provided as a part of an rt266 infant dual-heated evaqua2 breathing circuit, was found leaking water during patient use.There was no patient harm reported.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chamber was not returned to fisher & paykel (f&p) healthcare.Our investigation is based on the information, video and photographs provided, and our knowledge of the product.Results: review of the provided photographs and video of the subject mr290v vented autofeed humidification chamber confirmed the reported leak.Additionally, a dent in the chamber base was observed.Conclusion: the base of the returned humidification chamber was found to be dented.Without the return of the subject device, we are unable to confirm the cause of the leak, however the presence of the dent indicates that he chamber might had been dropped, posibbly resulting in the reported water leak.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber 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 subject mr290v chamber would have met the required specification at the time of production.The user instructions that accompany the rt266 breathing circuit state 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 distributor reported on behalf of a healthcare facility in china that an mr290v autofeed humidification chamber, provided as a part of an rt266 infant dual-heated evaqua2 breathing circuit, was found leaking water during patient use.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: 21280320
• Report Number: 9611451-2025-00103
• Device Sequence Number: 9320411
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2102819614(11)231006(17)281006
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103767
• 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): 01/23/2025

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 Expiration Date: 10/06/2023
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2102819614
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2023
• 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