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

Model Number MR290VX

Device Problem Crack (1135)

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

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A distributor reported on behalf of a healthcare facility in china, that a mr290vx vented autofeed humidification chamber dome was found cracked prior to patient use.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in china that a mr290vx vented autofeed humidification chamber dome was found cracked prior to patient use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint mr290vx vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr290vx chamber confirmed two vertical cracks propagating from the chamber base to above the water level marking and connected with each other at the chamber base.Stress and whitening marks were observed along the cracks.Horizontal cracks were also observed propagating out from the vertical cracks.Tiny stress marks were observed on the other side of the chamber.Analysis of the returned chamber did not identify any manufacturing issues that would have contributed to the reported damage.Conclusion: we are unable to determine the root cause of the chamber cracks.Our investigation indicates that the cracks were due to mechanical stress.The stress source was unable to be identified.The mr290 chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290 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 mr290vx chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290vx 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" "ensure there is water supply connected to the chamber and that water is present within the chamber" "do not use the chamber if the seals are not intact when received, or if it has been dropped.".

• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16585723
• MDR Text Key: 311961196
• Report Number: 9611451-2023-00243
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430205
• UDI-Public: (01)09420012430205(10)2102268141(11)220719(17)270719
• 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,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

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: MR290VX
• Device Catalogue Number: MR290VX
• Device Lot Number: 2102268141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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 RT265 INFANT EVAQUA2 BREATHING CIRCUIT.; F&P RT265 INFANT EVAQUA2 BREATHING CIRCUIT.