MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT DUAL HEATED BREATHING CIRCUIT; BTT

Model Number RT200

Device Problem Gas/Air Leak (2946)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Section g4: the rt200 adult dual 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.Section h10: the subject rt200 adult dual heated breathing circuit has been requested to be returned to nz for evaluation.We will provide a follow up report on completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in china that a rt200 adult dual heated breathing circuit failed the ventilator leak test before use.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in china that a rt200 adult dual heated breathing circuit failed the ventilator leak test before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Section g4: the rt200 adult dual 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.Section h11: method: the subject rt200 adult dual heated breathing circuit was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that a rt200 adult dual heated breathing circuit failed the ventilator leak test prior to patient use.Conclusion: the subject rt200 adult dual heated breathing circuit was requested to be returned for evaluation, however, it was not provided.Without the return of the complaint device, we are unable to confirm, or determine the cause of the reported fault.All rt200 adult dual heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt200 adult dual heated breathing circuit show in pictorial format the correct set-up of the circuit and also 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 connecting to a patient." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

• Brand Name: ADULT DUAL HEATED BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 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: 18377748
• MDR Text Key: 331385278
• Report Number: 9611451-2023-01192
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: SEE H11
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 2102461604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2022
• 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