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

Model Number RT265

Device Problem Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant dual heated evaqua2 breathing was returned to fph in (b)(4) for evaluation.It was visually inspected and pressure tested.Results: the rt265 infant breathing circuit was returned with disassembled elbow and swivel; however, no damaged was observed to either component.The swivel and elbow were reassembled and formed a tight fit when reconnected to the breathing circuit.The breathing circuit was subsequently pressure tested and the result was within specification.A lot check revealed no other complaints of this nature for lot number 160225.Conclusion: we were unable to determine what had caused the reported fault with the elbow and swivel of the subject infant breathing circuit.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 hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the y-piece and swivel of an rt265 infant dual heated evaqua2 breathing had loose connection.This was observed before use on a patient.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING
• 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: raymond yan ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6101300
• MDR Text Key: 59859629
• Report Number: 9611451-2016-00771
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• 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
• Device Lot Number: 160225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• 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