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

Model Number RT265

Device Problems Failure of Device to Self-Test (2937); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in thailand, via a fisher & paykel healthcare (f&p) field representative, that a rt265 infant dual-heated evaqua2 breathing circuit failed the pre-use ventilator leak test.There was no patient involvement.

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in thailand, via a fisher & paykel healthcare (f&p) field representative, that a rt265 infant dual-heated evaqua2 breathing circuit failed the pre-use ventilator leak test.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of our product.Results: the customer reported that a rt265 infant dual-heated evaqua2 breathing circuit failed the pre-use ventilator leak test.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt265 infant dual-heated evaqua2 breathing circuit state 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: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: 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: 14902309
• MDR Text Key: 296478907
• Report Number: 9611451-2022-00593
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012430205
• UDI-Public: (01)09420012430205(10)2101782214(11)210831
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Device Lot Number: 2101782214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1