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

Model Number	RT380
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in japan reported on behalf of a healthcare facility that two rt380 adult dual heated evaqua2 breathing circuits were found with a crack on the expiratory limb.The distributor also reported that the subject circuits were in use for approximately one month.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Section d4: includes the device details for one rt380 circuit.The device details for the second affected unit remain unknown.Method: the subject rt380 adult dual heated evaqua2 breathing circuits were not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is based on the photographs and description of events provided by the customer, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the provided photographs confirmed that the subject rt380 adult dual heated evaqua2 breathing circuits had visible cracks on the expiratory tubing.Conclusion: without the return of the subject rt380 adult dual heated evaqua2 breathing circuits, f&p healthcare's investigation was unable to determine the root cause of the reported damage.However, based on the provided photographs, it is likely that the damage to the rt380 breathing circuits may be associated with the circuit being used for one month, which exceeds the maximum recommended use duration of 14 days as stated in the user instructions.All rt380 adult dual-heated evaqua2 breathing circuit are visually inspected, as well as pressure and flow tested during production, and those that fail the test are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt380 adult dual-heated evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: do not use beyond 14 days maximum duration of use.Visually inspect breathing sets for damage (e.G., a crushed tube or cracked connector) before use, and replace if damaged.Do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure.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: 24602105
• Report Number: 9611451-2026-00918
• Device Sequence Number: 18238738
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2103297167(11)240816(17)290816
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 2103297167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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 MR850 RESPIRATORY HUMIDIFIER; LÖWENSTEIN ELISA 300
• Patient Sex: Unknown