MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT

Model Number RT206

Device Problem Gas/Air Leak (2946)

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

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt206 adult inspiratory heated breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.We are currently in the process of completing 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 thailand, via a fisher & paykel healthcare (f&p) field representative, that the water trap of a rt206 adult inspiratory heated breathing circuit was found leaking during the pre-use ventilator leak test.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in thailand, via a fisher & paykel healthcare (f&p) field representative, that the water trap of a rt206 adult inspiratory heated breathing circuit was found leaking during the pre-use ventilator leak test.There was no patient involvement.

Manufacturer Narrative

(b)(4).The rt206 adult inspiratory heated breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Method: the complaint rt206 adult inspiratory heated breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information from the customer, and our knowledge of the product.Results: the customer reported that the water trap of a rt206 adult inspiratory heated breathing circuit was found leaking during the pre-use ventilator leak test.Conclusion: without the the return of the complaint device, we are unable to determine the cause of the reported event.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.The user instructions that accompany the rt206 adult inspiratory heated breathing circuit 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 connection to a patient." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

• Brand Name: ADULT INSPIRATORY HEATED BREATHING CIRCUIT
• Type of Device: BTT
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17214077
• MDR Text Key: 317987175
• Report Number: 9611451-2023-00590
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430380
• UDI-Public: (01)09420012430380(10)2102288733(11)220803
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT206
• Device Catalogue Number: RT206
• Device Lot Number: 2102288733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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