MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED AUTOFEED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number MR290V

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/24/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The subject mr290v vented autofeed humidification chamber has been requested to be returned to fisher & paykel healthcare in new zealand for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in china reported that a mr290v vented autofeed humidification chamber provided with a rt226 infant low flow breathing circuit was found leaking prior to patient use.There was no reported patient consequence.

Event Description

A healthcare facility in china reported that a mr290v vented autofeed humidification chamber provided with a rt226 infant low flow breathing circuit was found leaking water during patient use.The healthcare facility reported that the chamber had been in use for 3-4 hours.There was no reported patient consequence.

Manufacturer Narrative

(b)(6) method: the subject rt226 infant low flow breathing circuit was requested for return to new zealand for analysis, however, the healthcare facility reported that is had been discarded.Our investigation is therefore based on the information provided by the healthcare facility and our knowledge of the product.Results: the healthcare facility provided additional information clarifying that the subject mr290v vented autofeed humidification chamber provided with a rt266 infant low flow breathing circuit was leaking water between the water feedset tubing and the water source.This was identified after 3-4 hours of patient use.Conclusion: the subject device or photographs were not provided to f&p healthcare for analysis.Therefore, we are unable to determine the cause of the reported water feedset leakage.However, it is possible to tear the water feedset tubing if excessive force is applied.The mr290v humidification chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290v chamber is pressure tested following the manufacturing process and any holes or leaks in the feedset would be identified during this process.Destructive pull testing of the water feedset is also conducted during the manufacturing process.The subject mr290v humidification chamber would have met the required specifications at the time of production.The user instructions that accompany the mr290v vented autofeed humidification chamber state the following: - "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged." - "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.".

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• 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: 19150094
• MDR Text Key: 340806374
• Report Number: 9611451-2024-00294
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K934140
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/21/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 9 DA
• Patient Sex: Male