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

Model Number RT266

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare in (b)(4) for evaluation.Our investigation is based on the information and photographs provided by the hospital.Results: the photographs showed scratches and pinholes on the surface of the inspiratory limb.Conclusion: without the complaint device, we were unable to determine what had caused the leaking on the inspiratory limb.However, it was noted that the subject breathing circuit was used on a patient for a month.All rt266 infant dual heated evaqua2 breathing circuit 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.Moreover, the hospital reported that the damage occurred after a period of use, which suggests that the observed leaking happened after the subject rt266 infant breathing circuit 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.".

Event Description

A hospital in (b)(6) reported via a distributor that an air leak was observed coming from the inspiratory limb of an rt266 infant dual heated evaqua2 breathing circuit after a month of patient use.It was also reported that the inspiratory limb had scratches and pinholes.No patient consequence was reported.

• Brand Name: INFANT 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: irfanali kermalli ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6635823
• MDR Text Key: 77453466
• Report Number: 9611451-2017-00519
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• 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?: No
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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