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

Model Number MR290V

Device Problems Gas/Air Leak (2946); Scratched Material (3020)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290v vented autofeed humidification chamber is currently undergoing investigation at fisher & paykel healthcare (f&p).We will provide a follow up report upon completion of investigation.

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel (f&p) healthcare field representative that a mr290v vented autofeed humidification chamber was broken/damaged when taken out of box.There was no patient consequence reported.

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel (f&p) healthcare field representative, that during set up the circuit failed a leak test.The user then identified cracks in the side of the mr290v vented autofeed humidification chamber.There was no patient consequence reported.

Manufacturer Narrative

(b)(4) method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel (f&p) healthcare in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr290v chamber identified multiple vertical cracks around the base of the chamber dome.The printing on the outside of the chamber dome was also observed to be smeared.Conclusion: the smeared print on the chamber dome indicates that it may have been in contact with a solution containing alcohol.This could also cause the cracking observed in the chamber dome.The mr290 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 to check for any leaks present in the chamber dome 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 mr290v chambers would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber 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: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: HUMIDIFICATION CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCRE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL 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: 18853016
• MDR Text Key: 337473283
• Report Number: 9611451-2024-00154
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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 Model Number: MR290V
• Device Catalogue Number: MR290V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• 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
• Treatment: HUMIDIFIER: MR850; HUMIDIFIER: MR850; VENTILATOR: V500; VENTILATOR: V500