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

Model Number RT265

Device Problems Connection Problem (2900); Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the that the pressure line of an rt265 infant dual heated evaqua2 breathing circuit is not staying connected.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and a photograph provided by the customer and our knowledge of the product.Results: visual inspection of the photograph revealed no damage to the pressure line port or the pressure line elbow.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt265 circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject rt265 circuit would have met the required specifications at 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 canada reported via a fisher & paykel healthcare (f&p) field representative that the that the pressure line of an rt265 infant dual heated evaqua2 breathing circuit is not staying connected.There was no reported 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13361583
• MDR Text Key: 286643913
• Report Number: 9611451-2022-00034
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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