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

Model Number RT380

Device Problems Crack (1135); Device Issue (2379)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 adult dual heated evaqua2 breathing circuits are currently en-route to fph in (b)(4) for evaluation, to determine if they had a malfunction which might have caused or contributed to the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) representative that some rt380 adult dual heated evaqua2 breathing circuits were cracked at the 'y' connector piece.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult dual heated evaqua2 breathing circuits were not received at fph in (b)(4) for evaluation.Instead, two sealed rt380 adult dual heated evaqua2 breathing circuit kits were returned and visually inspected.One rt380 breathing circuit kit was opened for pressure testing.Questions were also sent to the customer however no response was received despite at least one follow-up attempt.Results: visual inspection revealed no damage to the sealed breathing circuits.The pressure test result was within specification.Conclusion: we were unable to determine what may have caused the fault as reported by the customer as no complaint devices were returned for investigation.No fault was found with the returned sealed devices.All rt380 adult dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit state: "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers." "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 via a fisher & paykel healthcare (fph) representative that some rt380 adult dual heated evaqua2 breathing circuits were cracked at the 'y' connector piece.No patient consequence was reported.

• Brand Name: ADULT 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: jon stevens ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6265106
• MDR Text Key: 65346600
• Report Number: 9611451-2017-00020
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122432
• 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: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 2100006956
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2015
• 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