MAUDE Adverse Event Report: Fisher & Paykel Healthcare Ltd F&P Evaqua 2; Breathing Circuit

Model Number	RT266
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in finland reported via a fisher & paykel (f&p) healthcare field representative that an mr290v vented autofeed humidification chamber provided with an rt266 infant dual-heated evaqua2 breathing circuit was found to be overfilling with water within 5 minutes of commencing patient use.There was no reported patient harm.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chamber provided with the rt266 infant dual-heated evaqua2 breathing circuit has been returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.We will provide a follow up report upon completion of our investigation.

• Brand Name: F&P Evaqua 2
• 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 ; +1(949)434-1005
• MDR Report Key: 50601785
• Report Number: 9611451-2026-02546
• Device Sequence Number: 21518285
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2104227814(11)260311(17)310311
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K103767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2104227814
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2026
• 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: B.Braun Aquasterile 500ml bottle; F&P MR850 Respiratory Humidifier; Servo Ventilator
• Patient Sex: Unknown