MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number	RT385
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt385 adult dual-heated evaqua2 breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan, that a rt385 adult dual-heated evaqua2 breathing circuit failed the ventilator leak test before use.There was no patient involvement.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan, that a rt385 adult dual-heated evaqua2 breathing circuit failed the ventilator leak test before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt385 adult dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and leak tested.Results: visual inspection identified no damage was found to any of the breathing circuits.Leak testing revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the reported event as there was no fault found with the returned device.All rt385 adult dual-heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our 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.".

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Common Device Name: BZE
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15992879
• Report Number: 9611451-2022-01188
• Device Sequence Number: 17573749
• Product Code: BZE
• UDI-Device Identifier: 09420012430472
• UDI-Public: (01)09420012430472(10)2101894059(11)211112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: 2101894059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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