MAUDE Adverse Event Report: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT265

Device Problems Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt265 infant dual heated evaqua2 breathing circuits are currently en route to fisher & paykel healthcare in (b)(4) for evaluation to determine if it had a malfunction, which could have caused or contributed to the reported event.We will provide a follow-up report once we have completed our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare field representative that the pressure line of an rt265 infant dual heated evaqua2 breathing circuit pops off during device set up.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: six pressure lines of rt265 infant dual heated evaqua2 breathing circuit were received at fisher & paykel healthcare in new zealand for evaluation and were visually inspected.Results: visual inspection of pressure lines revealed that a moulding defect was found on the elbow of pressure lines.Conclusion: we were unable to determine what caused the moulding defect of the pressure line elbow.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit states: "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 netherlands reported via a fisher & paykel healthcare field representative that the pressure line of an rt265 infant dual heated evaqua2 breathing circuit pops off during device set up.There was no patient involvement.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9567204
• MDR Text Key: 182335892
• Report Number: 9611451-2020-00032
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• 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
• Device Lot Number: 2100857984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2019
• 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