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

Model Number	RT280
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject rt280 breathing circuits have 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 (b)(6) reported via a fisher & paykel (f&p) healthcare representative, that two rt280 adult evaqua2 dual heated breathing circuits failed the ventilator leak test prior to patient use.There was no patient involvement reported.
Additional Manufacturer Narrative
(b)(4).Method: the subject rt280 adult dual heated evaqua2 breathing circuits and additional information were requested to be provided to fisher & paykel (f&p) healthcare in new zealand for evaluation.Neither the subject device nor the additional information was provided for evaluation.Our investigation is therefore based on the information provided by the healthcare facility, and our knowledge of the product.Results: the customer reported that two rt280 adult evaqua2 dual heated breathing circuits failed the ventilator leak test prior to patient use.Conclusion: based on the limited information provided by the healthcare facility and without the return of the subject device, we are unable to confirm the reported leak or determine the cause of the reported event.All rt280 adult dual heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject circuits would have met the required specifications at the time of production.The user instructions provided with the rt280 adult dual heated evaqua2 breathing circuit include the following: - visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.- ensure appropriate ventilator and 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.- check all connections are tight before use.
Event or Problem Description
A healthcare facility in michigan reported via a fisher & paykel (f&p) healthcare representative, that two rt280 adult evaqua2 dual heated breathing circuits failed the ventilator leak test prior to patient use.There was no patient involvement 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 21759098
• Report Number: 9611451-2025-00283
• Device Sequence Number: 8720799
• Product Code: BZE
• UDI-Device Identifier: 09420012430373
• UDI-Public: (01)09420012430373(10)2103338166(11)240912(17)290912
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: RT280
• Device Catalogue Number: RT280
• Device Lot Number: 2103338166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• 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