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

Model Number RT267

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt267 infant dual heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.Method: the complaint rt267 infant dual heated evaqua2 breathing circuits was returned to fisher & paykel healthcare regional office in india and was visually inspected.Results: visual inspection revealed multiple holes in the inspiratory limbs of the rt267 circuit.The holes are all located on the peaks of the tube with a rough edges.Conclusion: it is most likely the abrasion is due to transport or storage condition.All rt267 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject rt267 circuit would have met the required specification at the time of production.Our user instructions that accompany the rt267 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 distributor in (b)(4) reported via a fisher & paykel healthcare field representative that holes were found in the tubing of rt267 infant dual heated evaqua2 breathing circuits.There was no patient involvement.

• 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: faranak gomarooni ; 173 technology drive; suite100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 8380582
• MDR Text Key: 137847475
• Report Number: 9611451-2019-00179
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT267
• Device Catalogue Number: RT267
• Device Lot Number: 2100530392
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2019
• 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