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

Model Number RT265

Device Problems Disconnection (1171); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are in the process of obtaining the complaint (b)(4) breathing circuit.Once we have received the complaint device we will commence our investigation and submit a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via the (b)(6) that an rt265 infant dual-heated evaqua2 breathing circuit was leaking from the swivel connector.It was observed that the swivel connector would not stay coupled to the expiratory and inspiratory tubes.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation where it was visually inspected, pressure tested and the inspiratory and the expiratory limbs were resistance tested.Results: the swivel, which consists of two parts the swivel wye and elbow, was reassembled and formed a tight fit when reconnected.A visual inspection of the swivel revealed that there was a crack along one of the swivel wye ports.The circuit was pressure tested and the result was within specification.The resistance test revealed that the heater wire resistance of both circuit limbs was within specification.Conclusion: we were unable to determine the cause of the reported disconnection, as the swivel formed a tight fit with the circuit limbs when properly connected.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt265 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 the (b)(6) that an rt265 infant dual-heated evaqua2 breathing circuit was leaking from the swivel connector.It was observed that the swivel connector would not stay coupled to the inspiratory and expiratory limbs.No patient consequence was reported.

• 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: jon stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6197465
• MDR Text Key: 63069361
• Report Number: 9611451-2016-00909
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• 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