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

Model Number	RT205
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Section g4: the rt205 adult ventilator circuit is not sold in the usa but is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Section h11: fisher & paykel (f&p) healthcare is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in china reported that an rt205 adult ventilator circuit generated a ventilator leak alarm prior to patient use.There was no reported patient harm.
Additional Manufacturer Narrative
(b)(6).Section g4: the rt205 adult ventilator circuit is not sold in the usa but is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Section h11: method: the subject rt205 adult ventilator circuit and additional information was requested to be provided to fisher & paykel (f&p) healthcare for analysis.Results: the subject device could not be returned to f&p healthcare as it had been destroyed by the healthcare facility.Conclusion: based on the information provided by the healthcare facility and without the return of the subject device, we are unable to confirm or 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 rt205 adult ventilator circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject circuit would have met the required specifications at the time of production.The user instructions for the rt205 adult ventilator circuit include the following: - check all connections are tight before use.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- 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.
Event or Problem Description
A healthcare facility in china reported that an rt205 adult ventilator circuit generated a ventilator leak alarm prior to patient use.There was no reported patient harm.

• 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: 21878708
• Report Number: 9611451-2025-00348
• Device Sequence Number: 21025026
• Product Code: BZE
• UDI-Device Identifier: 09420012430410
• UDI-Public: (01)09420012430410(10)2103387227(11)241002(17)291002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: SEE H11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: RT205
• Device Catalogue Number: RT205
• Device Lot Number: 2103387227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown