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

Model Number RT268

Device Problems Leak/Splash (1354); Cut In Material (2454); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt268 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 k034026.Method: the complaint rt268 breathing circuit was returned to fisher & paykel healthcare.Visual inspection of the circuit was performed.Results:a cut was found in the inspiratory limb of the rt268 breathing circuit.A lot check revealed no other complaints for the lot number provided.Conclusion: it appears that the inspiratory limb of the rt268 breathing circuit was cut with a sharp object, which may have occured when opening the device box/bag with a sharp object such as a knife or box cutter.The also customer confirmed the use of a utility knife to open the circuit kit.Our user instructions that accompany the rt268 state the following: 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 to a fisher & paykel healthcare field representative that the inspiratory limb of an rt268 infant breathing circuit broke and that water was leaking from it.This was observed before use on a patient.

• 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 ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 5503126
• MDR Text Key: 40391120
• Report Number: 9611451-2016-00096
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: SEE H10
• 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: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT268
• Device Catalogue Number: RT268
• Device Lot Number: 150907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2015
• 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