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

Model Number RT265

Device Problem Device Issue (2379)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of conducting our investigation, to determine if the complaint rt265 infant dual-heated evaqua2 breathing circuits had a malfunction which caused or contributed to the reported event.We will submit a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that some rt265 infant dual-heated evaqua2 breathing circuits had broken at the swivel.The hospital was unable to provide any further information and had discarded the breathing circuits prior to reporting the event.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint rt265 infant dual-heated evaqua2 breathing circuits were not made available to fph in (b)(4) as the hospital had discarded them prior to the reported event.Our investigation is accordingly based on the information reported by the hospital, previous similar investigations, and our knowledge of the product.Without any complaint devices we are unable to determine what may have caused the swivel issue reported by the hospital.However it was reported that the hospital 'believes it might be user error' and that the alleged event "was caused when they pulled on it too hard'.The infant swivel and elbow are assembled using a machine to ensure a consistent tightness of connection.The swivel is then 100% visually inspected and pressure and flow tested as part of the infant breathing circuit before leaving the production line.Any breathing circuits that fail these tests are rejected.The subject rt265 infant breathing circuits would have met the required specification at the time of production.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit also 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 some rt265 infant dual-heated evaqua2 breathing circuits had broken at the swivel.The hospital was unable to provide any further information and had discarded the breathing circuits prior to reporting the event.No patient consequence 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: jon stevens ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6375302
• MDR Text Key: 68979092
• Report Number: 9611451-2017-00155
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• 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