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

Model Number RT265

Device Problems Disconnection (1171); Material Separation (1562)

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

Event Date 04/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt265 infant dual heated evaqua2 breathing circuit is currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the swivel of an rt265 infant dual-heated evaqua2 breathing circuit came apart during use.There was no reported patient consequence.

Manufacturer Narrative

Ps311152 method: the swivel and elbow of the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare for evaluation.The elbow and swivel were visually inspected and pressure tested.Results: the elbow and swivel were returned disassembled.No damage was observed to either component.The swivel and elbow were assembled together and the reassembled parts of the swivel formed a tight fit.Pressure testing revealed that the returned rt265 swivel assembly was within specification.Conclusion: we could not determine the caused the rt265 swivel to disassemble during use.The infant swivel and elbow are assembled using a machine to ensure a consistent tightness of connection.The swivel is then 100% pressure and flow tested as part of the infant breathing circuit before leaving the production line.Any breathing circuits that fail these tests are rejected.The subject rt265 infant dual heated evaqua2 breathing circuit would have met the required specification at the time of production.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit also 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 healthcare facility in germany reported that the swivel of an rt265 infant dual-heated evaqua2 breathing circuit came apart during use.There was no reported patient consequence.

• 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
• MDR Report Key: 8639152
• MDR Text Key: 146095597
• Report Number: 9611451-2019-00525
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1