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

Model Number RT265

Device Problems Decrease in Pressure (1490); Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt265 infant dual-heated evaqua2 breathing circuit is currently en-route to fph in (b)(4) for evaluation, to determine if it caused or contributed to the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A hospital in the uk reported via a fisher & paykel healthcare (fph) field representative that an rt265 infant dual-heated evaqua2 breathing circuit kept dropping in pressure when connected to a ventilator during setup.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was returned to fph in (b)(6) for investigation, where it was visually inspected and pressure tested.Results: visual inspection revealed no damage to the returned breathing circuit and dryline.The pressure test revealed that the subject breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the leak as reported by the customer as no fault was found with the returned device.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 circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit 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)(6) reported via a fisher & paykel healthcare (fph) field representative that an rt265 infant dual-heated evaqua2 breathing circuit kept dropping in pressure when connected to a ventilator during setup.There was no patient involvement.

• 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 dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6816019
• MDR Text Key: 83666178
• Report Number: 9611451-2017-00793
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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