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

Model Number RT266

Device Problems Crack (1135); Device Issue (2379); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

We are currently in the process of obtaining the complaint rt266 infant dual heated evaqua2 breathing circuits from the medical center for investigation to determine if they had a malfunction, which could have caused or contributed to the reported events.We will provide a follow up report once we have completed our evaluation.

Event Description

A medical center in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that four rt266 infant dual heated evaqua2 breathing circuits had a crack at the swivel adaptor and/or popping off during use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuits were not made available to fph in (b)(4) as the hospital had discarded them.Therefore, our investigation is based on a photograph of one complaint device and the information provided by the healthcare facility.Results: visual inspection of the photograph revealed a crack along one of the swivel wye ports and the elbow and swivel were disassembled.Conclusion: we are unable to determine what may have caused the crack in the swivel and why it dissembled during use.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specification prior to distribution.Our user instructions that accompany the rt266 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.- do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.

Event Description

A medical center in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that four rt266 infant dual heated evaqua2 breathing circuits had a crack at the swivel adaptor and/or were popping off during use.No patient consequence was reported.

• 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: jon stevens ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6386238
• MDR Text Key: 69329296
• Report Number: 9611451-2017-00150
• 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: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2100083021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• 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