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

Model Number RT265

Device Problem Disconnection (1171)

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

Event Type  malfunction  

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 based on the customer's description of event, photography and our knowledge of our product.Results: visual inspection of the photograph provided by the customer shows that the swivel elbow and wye have disassembled.No damages were observed to any of the swivel components.Conclusion: without the complaint device, we could not determine what caused the rt265 swivel to diassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.All rt265 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.".

Event Description

A distributor on behalf of a healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a swivel of rt265 infant dual heated evaqua2 breathing circuit was easily disconnected "right after starting to use".There was no reported patient consequence.

• 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
• MDR Report Key: 10261726
• MDR Text Key: 200042330
• Report Number: 9611451-2020-00621
• 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,distri
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2020
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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