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

Model Number MR290V

Device Problems Leak/Splash (1354); Overfill (2404)

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

Event Date 05/25/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Correction: section b5: initial interpretation of customer complaint indicated chamber leak.Clarification with the regional office confirmed the reported event was the chamber filling with water above the maximum water level line.Method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected and performance tested.Results: visual inspection of the returned chamber did not identify any damage or defects.Performance testing revealed 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.Overfilling of water is caused by both the primary and secondary float mechanisms in the mr290v vented autofeed humidification chamber being disabled.In circumstances where the primary float is disabled, the water may overfill above the black water level line of the chamber.However, the secondary float will serve as a backup to prevent the water from overflowing outside the chamber port and entering into the breathing circuit.All mr290v vented autofeed humidification chambers are functionally tested during production.Any chamber that failed is rejected.The subject mr290v chamber would have met the required specification at the time of production.The user instructions that accompany the mr290v vented autofeed humidification chamber specify 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.".

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) representative that a mr290v vented autofeed humidification chamber was filling with water above the maximum water level line prior patient use.There was no patient involvement.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: BTT
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14749973
• MDR Text Key: 295975804
• Report Number: 9611451-2022-00570
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• 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
• Device Lot Number: 211213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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