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

Model Number RT380

Device Problem Air Leak (1008)

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

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt380 breathing circuit was returned to fisher & paykel healthcare (b)(4) for inspection.The complaint device was pressure tested and submerged in a water bath to check for leaks.Result: the pressure test revealed that the complaint device did not perform within the required specification.The water bath test revealed that the leak was located at the elbow connector of the circuit's expiratory limb.Conclusion: we were unable determine the cause of the reported fault.However, it must be noted that we have not received a complaint of similar nature since 2013.All rt380 breathing circuits are pressure tested for leaks during production and those that fail these tests are rejected.This suggests that the leak developed after the complaint device was released for distribution.The user instructions that accompany the rt380 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.The user followed our user instructions correctly as the hospital found the leak during the ventilator leak test.

Event Description

A healthcare facility in (b)(6) reported that the rt380 evaqua2 adult breathing circuit did not pass the initial leak test of the pb980 ventilator when checked before use.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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 7467644
• MDR Text Key: 107223208
• Report Number: 9611451-2018-00337
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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: 171014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2017
• 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