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

Model Number RT265

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).All rt265 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt265 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 healthcare facility in (b)(6) reported that the port cap of a rt265 infant dual- heated breathing circuit came loose during use.There were no reported patient consequences.

• 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: 11174446
• MDR Text Key: 242169166
• Report Number: 9611451-2021-00042
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012430205
• UDI-Public: 010942001243020510
• 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,health professional,u
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• 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: 2101272830
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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