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

Model Number RT266

Device Problem Split (2537)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt266 infant dual-heated evaqua2 breathing circuits were recently received at fisher & paykel healthcare in (b)(4).We are currently in the process of conducting an investigation, to determine if the returned breathing circuits caused or contributed to the reported event.We will submit a follow-up report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported that some rt266 infant dual-heated evaqua2 breathing circuits had split at the seam on the dryline.This was discovered before patient use.

Manufacturer Narrative

(b)(4).Method: five complaint rt266 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare in (b)(4), and were visually inspected.Results: visual inspection revealed that three of the returned infant breathing circuits had split dryline cuff at the ventilator end.The ventilator end connectors were either loose or missing.The other two infant breathing circuits were found to have split dryline cuff at the chamber end.The chamber end connectors were either loose or missing.Conclusion: further investigation was conducted and it was determined that the splitting was due to a manufacturing related issue.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 infant breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt266 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 the (b)6) reported that some rt266 infant dual heated evaqua2 breathing circuits had split at the seam on the dryline.This was discovered before patient use.

• 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: irfan kermalli ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6606235
• MDR Text Key: 76681105
• Report Number: 9611451-2017-00503
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

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: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2100116496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 05/05/2017
• Supplement Dates FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• 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