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

Model Number RT265

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was returned to fisher and paykel healthcare in (b)(4) for evaluation, where it was visually inspected.Results: visual inspection revealed a cut to the expiratory limb of the subject breathing circuit.A lot check was not performed as lot information was not made available by the customer.Conclusion: based on the investigation conducted, the expiratory limb appears to have been cut with a sharp object, such as a knife or boxcutter during opening of the box or device bag.All rt265 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 subject breathing circuit was damaged after it was released for distribution.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 their distributor that an rt265 infant dual-heated evaqua2 breathing circuit was leaking.The event occurred 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: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5877784
• MDR Text Key: 52165806
• Report Number: 9611451-2016-00438
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• 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: 08/12/2016
• Date Manufacturer Received: 07/17/2016
• 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