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

Model Number RT380

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: three rt380 adult dual heated evaqua2 breathing circuits (two in sealed and one in an unsealed packaging bags) were returned to fph in (b)(4) and were visually inspected.Results: no physical damage was observed to the adult breathing circuits that were returned in sealed packaging bags.However, both the inspiratory and the expiratory limbs of the breathing circuit in an unsealed packaging bag had a cut in the tubings.The tubings appeared to have been cut with a sharp object.A lot check revealed no other complaints of this nature for lot number 150609.Conclusion: from the appearance and location of the damage to the tubings, we can conclude that the cuts were most likely caused by opening the box or packaging bags with a knife or box cutter.All rt380 adult breathing circuits are visually inspected and pressure tested for leaks prior to distribution.Any breathing circuit which does not pass the pressure test is discarded.The subject rt380 adult breathing circuit would have met the required specification at the time of production.This suggests that the affected breathing circuit was damaged post production.The user instructions that accompany the rt380 adult 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 alarm.".

Event Description

A healthcare facility in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that three rt380 adult dual heated evaqua2 breathing circuits failed the ventilator leak test.This was observed before use on a patient.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 5867222
• MDR Text Key: 51832459
• Report Number: 9611451-2016-00423
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122432
• 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
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 150609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• 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