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

Model Number RT206

Device Problem Leak/Splash (1354)

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

Event Date 11/22/2022

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.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 healthcare facility in china reported that a rt206 adult inspiratory heated breathing circuit triggered a leakage alarm after 1 day and 5 hours of use.There was no patient consequence.

Event Description

A healthcare facility in china reported that a rt206 adult inspiratory heated breathing circuit triggered a leakage alarm after 1 day and 5 hours of use.There was no patient consequence.

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) in new zealand.Our investigation is thus based on the information provided by the customer, and our knowledge of the product.Results: the healthcare facility reported that the rt206 adult inspiratory heated breathing circuit triggered a leakage alarm after 1 day and 5 hours of use.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.All rt206 adult inspiratory heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt206 adult inspiratory heated breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use, and replace if damaged." "check that the heater wire is evenly distributed along the circuit and not bunched or kinked." "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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16221765
• MDR Text Key: 307896848
• Report Number: 9611451-2023-00045
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430380
• UDI-Public: (01)09420012430380(10)2102055859(11)220225
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2023
• 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: 2102055859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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
• Treatment: PURITAN BENNET 840 VENTILATOR; PURITAN BENNET 840 VENTILATOR