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

Model Number	RT385
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the subject rt385 breathing circuit was not returned to fisher & paykel healthcare new zealand for evaluation.Our evaluation is therefore based on a photograph and the information provided by the healthcare facility, and our knowledge of the product.Results: review of the photograph provided confirmed that the ventilator pre-use leak test failed.Conclusion: based on the limited information provided by the healthcare facility and without the return of the subject device, we are unable to confirm the reported issue or determine the cause of the reported event.All rt385 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 rt385 adult dual-heated evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: -"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.".
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that an rt385 adult dual heated evaqua2 breathing circuit failed the ventilator leak test prior to patient use.There was no patient involvement 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 ; 8007923912
• MDR Report Key: 20808065
• Report Number: 9611451-2024-00883
• Device Sequence Number: 15778492
• Product Code: BZE
• UDI-Device Identifier: 09420012430472
• UDI-Public: (01)09420012430472(10)2102915160(11)231208(17)281208
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/02/2024

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: 2102915160
• 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: 11/02/2024
• Initial Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown