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

Model Number	RT225
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chamber provided with the rt225 infant ventilator circuit, additional information, and photographs were requested to be provided to fisher & paykel (f&p) healthcare in new zealand for evaluation.Results: the healthcare facility reported that the subject device was not available to be returned to f&p healthcare for evaluation as the device had been destroyed.Visual inspection of the photographs provided by the healthcare facility show a crack in the chamber's dome.Conclusion: based on the information provided by the healthcare facility and without the return of the subject device, we are unable to determine the cause of the damage to the mr290v vented autofeed humidification chamber.All mr290v vented autofeed humidification chambers are 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 vented autofeed humidification chamber would have met the required specifications at the time of production.The user instructions provided with the rt225 infant ventilator circuit include the following: - do not use the chamber if the seals are not intact when received, or if it has been dropped.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- ensure there is a water supply connected to the chamber and that water is present within the chamber.- 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 distributor reported on behalf of a healthcare facility in china that an mr290v vented autofeed humidification chamber provided with an rt225 infant 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: 21309457
• Report Number: 9611451-2025-00082
• Device Sequence Number: 8213874
• Product Code: BZE
• UDI-Device Identifier: 09420012431080
• UDI-Public: (01)09420012431080(10)2103070359(11)240404(17)290404
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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: RT225
• Device Catalogue Number: RT225
• Device Lot Number: 2103070359
• 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: 01/13/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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
• Patient Sex: Unknown