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

Model Number RT265

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2020

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 information provided by the customer and our knowledge of our product.Results: the customer reported that the rt265 circuit failed the 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." "set appropriate ventilator alarms.".

Event Description

A distributor reported on behalf of a healthcare facility in (b)(4), via a fisher & paykel healthcare field representative that a rt265 infant dual-heated evaqua2 breathing circuit failed the leak test before use.There was no patient involvement.

• 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: 10505920
• MDR Text Key: 206194709
• Report Number: 9611451-2020-00766
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012430205
• UDI-Public: 010942001243020510210101708411200221
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: 2101017084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• 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