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

Model Number MR290V

Device Problem Overfill (2404)

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

Event Date 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher and paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was overfilled before patient use.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher and paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber overfilled before patient use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the subject mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and performance tested.Results: visual inspection of the returned chamber did not identify any damage or defects.Performance testing confirmed that the chamber filled with water and stopped when the maximum water line was reached.Conclusion: we are unable to determine the cause of the reported event as no fault was found with the returned device.The mr290v vented autofeed humidification chamber is designed with both a primary and secondary float system.If there is a malfunction of the primary float system the water may rise above the maximum water level line however the secondary float system is designed to prevent any further overfilling.Mr290v vented autofeed humidification chambers are functionally tested during production.Any chamber that fails is rejected.The subject mr290v chamber would have met the required specification at the time of production.The user instructions that accompany the rt380 adult dual-heated evaqua2 breathing circuit specifies in the warning section "do not use the chamber if the water rises above the maximum water level line" along with a diagram directing the user to check the water level on the chamber.A written description of the meaning of the symbols used is also included in the user instructions.It also states the following: "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 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: 18044696
• MDR Text Key: 327055529
• Report Number: 9611451-2023-01026
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• 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
• Treatment: F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER