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

Model Number RT200

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

A healthcare facility in china reported that a (b)(6) vented autofeed humidification chamber provided with a rt200 adult dual heated breathing circuit was leaking water during patient use.There were no patient consequences reported.

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 mr290v vented autofeed humidification chamber were requested to be provided to fisher & paykel healthcare new zealand, however, neither were provided for evaluation.Our investigation is therefore based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that a (b)(6) vented autofeed humidification chamber provided with a rt200 adult dual heated breathing circuit was leaking water during patient use.Conclusion: without the complaint device or further details on the location of the leakage, we are unable to determine the cause of the reported issue.Every (b)(6) vented autofeed humidification chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject (b)(6) vented autofeed humidification chamber would have met the required specification at the time of production.Our user instructions that accompany the rt200 adult dual heated breathing circuit state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "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." - "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions could lead to a loss of ventilation pressure.".

• 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: 18665213
• MDR Text Key: 334885599
• Report Number: 9611451-2024-00075
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 2102555564
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2023
• 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
• Patient Age: 86 YR
• Patient Sex: Male