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

Model Number	RT210
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 new jersey reported that four rt210 adult ventilator circuits failed the ventilator leak test prior to patient use.The issue reportedly resolved when the mr290v vented autofeed humidification chambers provided with the rt210 adult ventilator circuits were replaced.There was no reported patient involvement.
Event or Problem Description
A healthcare facility in new jersey reported that four rt210 adult ventilator circuits failed the ventilator leak test prior to patient use.The issue reportedly resolved when the mr290v vented autofeed humidification chambers provided with the rt210 adult ventilator circuits were replaced.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chambers provided with the rt210 adult ventilator circuits and additional information was requested to be provided to fisher & paykel (f&p) healthcare new zealand for evaluation.Results: the subject devices were not returned to f&p healthcare for evaluation as they had been discarded by the healthcare facility.Conclusion: based on the information provided by the healthcare facility and without the return of the subject devices, we are unable to confirm or determine the cause of the reported issue.All mr290v vented autofeed humidification chambers are visually inspected during the manufacturing process.Additionally, every mr290v vented autofeed humidification chamber is leak tested at the completion of the assembly process.Any chamber which fails these tests is rejected.The subject mr290v vented autofeed humidification chamber would have met the required specification at the time of production.The user instructions for the rt210 adult ventilator circuits 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.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.- visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.

• 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: 21694496
• Report Number: 9611451-2025-00250
• Device Sequence Number: 9419959
• Product Code: BTT
• UDI-Device Identifier: 09420012430298
• UDI-Public: (01)09420012430298(10)2103523719(11)241206(17)291206
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K983112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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: RT210
• Device Catalogue Number: RT210
• Device Lot Number: 2103523719
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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