MAUDE Adverse Event Report: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT265

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are in the process of obtaining further information and the complaint devices for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the swivels of six rt265 infant dual-heated evaqua2 breathing circuits become detached during use.There was no reported patient consequence.

Event Description

A healthcare facility in illinois reported that the swivels of six rt265 infant dual-heated evaqua2 breathing circuits become detached during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: none of the six complaint devices were returned for investigation, however 32 sealed rt265 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare for evaluation.Results: the swivel elbows and swivel wyes of all 32 rt265 breathing circuits were found fully assembled.Conclusion: without the complaint devices, we could not determine what caused the rt265 swivels to disassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.All rt265 infant dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All rt265 circuits are visually inspected, pressure and flow tested during production and those that fail, are rejected.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit also 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." "set appropriate ventilator alarms.".

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9294117
• MDR Text Key: 178583606
• Report Number: 9611451-2019-01081
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• 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: 2100800481
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2019
• 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