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

Model Number RT265

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare in (b)(4) for evaluation.Several attempts to obtain further information and the complaint device from the healthcare facility were made.Without the return of the complaint device we are not able to determine what may have caused the reported event described by the customer.All rt265 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.A circuit with this damage would not have passed our testing.Our user instructions that accompany the rt265 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 (b)(6) reported via a distributor that the rt265 infant dual heated evaqua2 breathing circuit is circuit is "not working properly/broken".The customer further reported that the circuit failed the initial ventilator leak test prior to patient use.This was found prior to patient use.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7737498
• MDR Text Key: 115670739
• Report Number: 9611451-2018-00636
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/31/2018
• 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