MAUDE Adverse Event Report: ADULT DUAL HEATED BREATHING CIRCUIT; BTT

Model Number RT200

Device Problems Connection Problem (2900); Gas/Air Leak (2946)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt200 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 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 (b)(6), via a fisher & paykel healthcare (f&p) field representative, that the temperature probe could not be connected to the rt200 adult breathing circuit during set up and failed the ventilator pre-use test.There was no patient involvement.

Manufacturer Narrative

(b)(4).The rt200 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 rt200 adult dual-heated breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection of the returned circuit revealed that the grommet of the rt200 adult dual-heated breathing circuit was incorrectly assembled in the inspiratory elbow.Conclusion: we are unable to determine the root cause of the event, however the grommet was likely incorrectly assembled during production.All rt200 adult dual heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt200 adult dual heated breathing circuit state: ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Check all connections are tight before use.

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that the rt200 adult breathing circuit failed the ventilator pre-use test.There was no patient involvement.

• Brand Name: ADULT DUAL HEATED BREATHING CIRCUIT
• Type of Device: BTT
• MDR Report Key: 12163766
• MDR Text Key: 263426128
• Report Number: 9611451-2021-00794
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430328
• UDI-Public: (01)09420012430328(10)2101366580(11)201102
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT200
• Device Catalogue Number: RT200
• Device Lot Number: 2101366580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2020
• 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