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

Model Number RT266

Device Problems Disconnection (1171); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare facility in (b)(6) reported that the swivel of a rt266 infant dual heated evaqua2 breathing circuit disassembled during use.There was no patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuits were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the customer's description of event, photography and our knowledge of our product.Conclusion: the customer reported that the swivel of the rt266 disassembled.Without the complaint device, we could not determine what caused the rt266 swivel to dissemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.All rt266 dual-heated evaqua2 breathing circuits are designed to conform to iso: 5367.All rt266 circuits are visually inspected, pressure and flow tested during production and those that fail, are rejected.The user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuits 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.'.

Event Description

A healthcare facility in ohio reported that the swivel of a rt266 infant dual heated evaqua2 breathing circuit disassembled during use.There was no patient consequences.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9470720
• MDR Text Key: 181605171
• Report Number: 9611451-2019-01211
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2100799293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2019
• 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