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 Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt265 breathing circuit was not returned to fisher & paykel healthcare for evaluation.Further information was sought about the incident and a request was made for the device or photographs, but we did not receive any response.The complaint circuit was not returned and there was not enough information provided by the customer to indicate what might have caused the disconnection.We were therefore unable to determine if the disconnection was due to the breathing circuit being set up under tension or due to a fault with the complaint device.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.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 hospital in (b)(6) reported that the rt265 infant dual-heated evaqua2 breathing circuit became disconnected at the y-piece during use on a patient and when they reconnected it, it subsequently became disconnected again.There was no 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6187889
• MDR Text Key: 62803147
• Report Number: 9611451-2016-00884
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2016
• 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