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

Model Number MR290V

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 03/19/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare field representative that an mr290 humidification chamber had deformed after they left the chamber setup with an mr850 humidifier without air flow for one hour.This occurred prior to patient use.

Manufacturer Narrative

Method: the complaint mr290v vented autofeed humdification chamber was returned to fisher & paykel healthcare in (b)(4) and was visually inspected.Results: visual inspection revealed that both of the chamber ports were deformed.The hospital reported that the mr290v chamber was set up with an mr850 humidifier, which was powered on and humming v ventilator which was in standby mode (no air flow).The setup also included an impedance valve on one of the chamber ports.A lot check revealed no other similar complaints for lot number 130519.Conclusion: it is most likely that the deformation of the chamber dome is due to the restricted flow caused by the humming v ventilator being in standby mode.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 caused at least one of the ports to deform.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 HUMIDIFICATION CHAMBER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216
• MDR Report Key: 3754917
• MDR Text Key: 4417776
• Report Number: 9611451-2014-00347
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• 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: 130519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2014
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2013
• 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: HUMMING V VENTILATOR; FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER