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

Model Number MR290V

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that the port of an mr290 humidification chamber had deformed after three days of use.The mr290v chamber was set up with an mr850 humidifier and a humming v ventilator.The customer has confirmed that the power to the flow source was turned off whilst the humidifier was kept on.This was found before use on a patient.

Manufacturer Narrative

Method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare in (b)(4) and was visually inspected.Results: visual inspection revealed that one of the chamber ports was deformed.The mr290v chamber was set up with an mr850 humidifier and humming v ventilator.The customer has confirmed that the power to the flow source was turned off whilst the humidifier was kept on.The setup also included an impedance valve on one of the chamber ports.A lot check revealed no other similar complaints for lot number 140305.Conclusion: the deformation of the port most likely occurred due to the flow source being turned off whilst the humidifier was kept on.The user instructions were not followed as the humidifier should not be turned on when there is no gas flow.No air flow through the chamber results in excessive heat inside the chamber which may cause the ports to deform.The weight of the impedance valve will also have contributed to the deformation of the port.As part of our manufacturing process, every mr290 chamber undergoes pressure testing for potential leaks and those that fail are rejected.In addition, a visual inspection is performed after the port caps are assembled on to the chamber on the production line.Any product which fails this visual inspection is rejected.The user instructions that accompany the mr850 humidifier state: - if gas flow is interrupted turn the humidifier off.

• Brand Name: VENTED AUTOFEED 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4292380
• MDR Text Key: 5085605
• Report Number: 9611451-2014-00897
• 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
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• 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: 140305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2014
• 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: FISHER & PAYKEL MR850 HUMIDIFIER; HUMMING V VENTILATOR