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

Model Number RT265

Device Problems Crack (1135); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

We are currently in the process of obtaining further information from the hospital to determine if the complaint breathing circuit caused or contributed to the reported event.We are also attempting to obtain the subject complaint device for further investigation.We will provide a follow up report once we have completed our evaluation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the connector of the rt265 infant dual-heated evaqua2 breathing circuit "has split".No patient involvement was reported.

Manufacturer Narrative

(b)(4).The complaint rt265 infant dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare for investigation.Our investigation is accordingly based on the information provided by the healthcare facility, and the results of previous investigations on similar complaints.Results / conclusion: we are not be able to determine definitively the root cause of the reported fault.However, investigations into this issue have determined that the cracking has most likely occurred due to improperly mixed material in the batch.We have since contacted the supplier and arranged for them to supply the molding material with the two parts already mixed.We anticipate that this will resolve the issue and the project to implement this change is currently in process.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 circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuits 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)(4) reported via a fisher & paykel healthcare (fph) field representative that the connector of the rt265 infant dual-heated evaqua2 breathing circuit "has split".No patient involvement was reported.

• 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: irfanali kermalli ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6529013
• MDR Text Key: 74162939
• Report Number: 9611451-2017-00379
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• 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
• Patient Outcome(s): Congenital Anomaly