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	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The subject rt205 adult ventilator circuit 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 japan that an rt205 adult ventilator circuit failed the ventilator leak test prior to patient use.There was no patient involvement.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that an rt205 adult ventilator circuit failed the ventilator leak test prior to patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).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.Method: the subject rt206 breathing circuit was returned to fisher & paykel healthcare in new zealand where it was visually inspected, and leak tested.Results: visual inspection of the returned device confirmed no damage to any part of the breathing circuit.Leak testing confirmed that the circuit was out of specification.Further investigation confirmed that the leak was coming through a bulge in the bowl of the water trap, affecting the seal between the lid and the bowl.Conclusion: the reported leak was confirmed and may have been due to misassembly, leading to the water trap bowl not fully engaging with the lid.The water trap of the breathing circuit consists of two parts, a lid and a bowl, which can be separated to allow the caregiver to empty the water trap.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.The user instructions that accompany the rt206 adult inspiratory heated breathing circuit state 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." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

• 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: 21579468
• Report Number: 9611451-2025-00219
• Device Sequence Number: 12985719
• Product Code: BZE
• UDI-Device Identifier: 09420012430410
• UDI-Public: (01)09420012430410(10)2103331790(11)240904(17)290904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/13/2025

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: 2103331790
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER; F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER; PURITAN BENNET 980 VENTILATOR; PURITAN BENNET 980 VENTILATOR
• Patient Sex: Unknown