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

Model Number RT266

Device Problems Leak/Splash (1354); Cut In Material (2454)

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

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in (b)(4) for investigation.The complaint device was visually inspected.Results: visual inspection of the complaint circuit revealed cut-like damage to the inspiratory limb.A lot check revealed no other complaints of this nature for the lot number provided.Conclusion: the damaged inspiratory limb of the complaint circuit appears to have been damaged with a sharp object.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.This suggests that the damage occurred to the circuit after it was released for distribution.Our user instructions that accompany the rt266 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; do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.

Event Description

A hospital in (b)(6) reported via a distributor that the inspiratory limb of an rt266 infant dual heated evaqua2 breathing circuit was leaking after 4 or 5 days of use.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: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5610392
• MDR Text Key: 43716723
• Report Number: 9611451-2016-00173
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• 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: 150718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2015
• 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