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

Model Number RT266

Device Problems Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative that a rt266 infant dual heated evaqua2 breathing circuit failed the pre-use leak test.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and pressure tested.Results: visual inspection revealed no damage or defect with the returned breathing circuit or the dryline.Pressure testing revealed that the breathing circuit was outside of specification.A waterbath test identified a small leak between the elbow connector and elbow collar.Conclusion: we were unable to determine the cause of the leak.All rt266 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 rt266 infant dual heated evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states 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." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative that a rt266 infant dual heated evaqua2 breathing circuit failed the pre-use leak test.There was no patient involvement.

• 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: faranak gomarooni ; 17400 laguna canyon road; suite #300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14403992
• MDR Text Key: 295494067
• Report Number: 9611451-2022-00459
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2101864970(11)211026
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2101864970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• 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
• Treatment: PURITAN BENNETT 980 VENTILATOR; PURITAN BENNETT 980 VENTILATOR