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

Model Number	RT385
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in china reported that an rt385 adult ventilator circuit dual heated with evaqua technology was found cracked prior to patient use.There was no patient involvement.
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.
Additional Manufacturer Narrative
(b)(4).Method: the subject rt385 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel (f&p) healthcare for evaluation.Our evaluation is therefore based on the information and photographs provided by the healthcare facility, and our knowledge of the product.Results: review of the provided photographs confirmed presence a cut-like damage on the expiraotry tube.Conclusion: without the return of the subject device, we are unable to confirm the cause of the reported damage.However, the damage might have occurred while opening the packaging.All rt385 adult dual heated evaqua2 breathing circuits 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 rt385 adult dual heated evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.Check all connections are tight before use.Do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.Ensure appropriate ventilator and flow source alarms are set before connecting breathing set to patient.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.
Event or Problem Description
A healthcare facility in china reported that an rt385 adult ventilator circuit dual heated with evaqua technology was found cracked prior to patient use.There was no patient involvement.

• 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: 21351853
• Report Number: 9611451-2025-00126
• Device Sequence Number: 7835879
• Product Code: BZE
• UDI-Device Identifier: 09420012430472
• UDI-Public: (01)09420012430472(10)2102829431(11)231012(17)281012
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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
• Device Model Number: RT385
• Device Catalogue Number: RT385
• Device Lot Number: 2102829431
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 02/23/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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