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

Model Number RT266

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt266 breathing circuit is currently en route to fisher & paykel healthcare in (b)(4) for investigation.We will provide a follow up report upon conclusion of our investigation.

Event Description

A distributor in (b)(4) reported that an rt266 infant dual-heated evaqua2 breathing circuits was exhibiting leak when connected to a ventilator and there were holes in the tubing.This was found before patient use.

Manufacturer Narrative

(b)(6) method: the complaint rt266 breathing circuit was not returned to fisher & paykel healthcare in (b)(6) for investigation.Our investigation is based on information and a photograph provided and our knowledge of the product.Results: the photograph showed that the inspiratory limb of the circuit was damaged and appeared to have a series of small holes in a section of the tubing.Conclusions: without a device to examine, we are unable to determine the exact nature and cause of the reported damage.However we were informed by our india office that the damage most likely occurred while the product was in stoirage at the distributor's facility or during transport from the distributor to the customer.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 healthcare facility reported that the damage was observed during use, which suggests that the complaint breathing circuits became damaged after they were released for distribution.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 distributor in (b)(6) reported that an rt266 infant dual-heated evaqua2 breathing circuits was exhibiting leak when connected to a ventilator and that there were holes in the tubing.This was found 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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6881773
• MDR Text Key: 87642384
• Report Number: 9611451-2017-00888
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• 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: 2100187882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2017
• 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