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

Model Number MR290V

Device Problem Leak/Splash (1354)

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

Event Date 03/29/2024

Event Type  malfunction  

Event Description

A mr290v vented autofeed humidification chamber was leaking water after seven days of patient use.There was no patient harm reported.

Manufacturer Narrative

(b)(4).Method: the subject mr290v vented auto feed humidification chamber was not returned to fisher & paykel healthcare for evaluation, therefore, our investigation is based off the photographs provided by the healthcare facility and our knowledge of the product.Results: visual inspection of the photographs provided confirmed a vertical crack near the base of the chamber dome.Brown residue was also visible on the base of the dome.Conclusion: the subject device was requested to be returned for investigation, however, it was not provided and we are therefore, unable to determine the cause of the leak.Our user instructions that accompany the mr290v vented auto feed humidification chamber state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "ensure appropriate ventilator and flow source alarms are set before connecting breathing set to 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." "do not use the chamber if the seals are not intact when received, or if it has been dropped.".

• Brand Name: VENTED AUTOFEED HUMIFICATION CHAMBER
• Type of Device: HUMIDIFICATION 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: 19122198
• MDR Text Key: 340448206
• Report Number: 9611451-2024-00277
• 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,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/02/2024

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 Expiration Date: 07/23/2023
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2023
• 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