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

Model Number	RT385
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Method: the subject mr290v vented autofeed humidification chamber provided with an rt385 adult dual heated evaqua2 breathing 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 neither the subject device nor photographs were available to be returned to f&p healthcare for evaluation as the device had been disposed of.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 event.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 mr290v vented autofeed humidification chambers are visually inspected during the manufacturing process.Additionally, every mr290v vented autofeed humidification chamber is leak tested at the completed of the assembly process.Any chamber which fails these tests is rejected.The subject mr290v humidification chamber would have met the required specifications at the time of production.The subject mr290v vented autofeed humidification chamber would have met the required specification at the time of production.The user instructions for the rt385 adult dual heated evaqua2 breathing 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
Aa healthcare facility in china reported that an mr290v vented autofeed humidification chamber provided with an rt385 adult dual heated evaqua2 breathing circuit was found leaking water during use.There was no 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: 21023281
• Report Number: 9611451-2024-00959
• Device Sequence Number: 12844408
• Product Code: BZE
• UDI-Device Identifier: 09420012430472
• UDI-Public: (01)09420012430472(10)2102863884(11)231102(17)281102
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2024

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: RT385
• Device Catalogue Number: RT385
• Device Lot Number: 2102863884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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