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

Model Number RT266

Device Problems Device Slipped (1584); Gas/Air Leak (2946)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt266 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 and paykel healthcare (f&p) field representative, that the temperature probe was "popping out" of the inspiratory limb of a rt266 infant dual-heated evaqua2 breathing circuit during use.There was no patient consequence.

Manufacturer Narrative

Ps(b)(4).Corrected data: section d9 device available for evaluation? no.Section h3 device evaluated by manufacturer? other method: the complaint rt266 infant dual-heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) in new zealand for investigation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: customer reported that the temperature probe was "popping out" of the inspiratory limb of a rt266 infant dual-heated evaqua2 breathing circuit during use.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt266 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt266 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." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

Event Description

A healthcare facility in iowa reported via a fisher and paykel healthcare (f&p) field representative, that the temperature probe was "popping out" of the inspiratory limb of a rt266 infant dual-heated evaqua2 breathing circuit during use.There was no 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
• 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: 14163996
• MDR Text Key: 294605341
• Report Number: 9611451-2022-00378
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2101817281(11)210929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• 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: 2101817281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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