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

Model Number MR290V

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 07/04/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that the water feedset tube on an mr290v vented autofeed humidification chamber from an rt340 adult dual heated evaqua breathing circuit kit disconnected during set up.This was found prior to patient use.

Manufacturer Narrative

(b)(4).Method: the complaint mr290v vented humidification chamber was returned to fisher & paykel healthcare in (b)(4) where it was visually inspected.Results: visual inspection revealed that the feedset tube was separated from the chamber at the connection to the chamber dome.Glue was noted around the feedset tube.A lot check revealed no other complaints of this nature for lot 041119.Conclusion: we are unable to determine what may have caused the feedset tube to separate from the chamber dome.All chambers are pressure tested before they leave the production line and any holes or leaks in the feedset are identified during this process.Any chamber that fails is rejected.This suggests that the feedset tube separated from the chamber dome after it was released for distribution.We have conducted extensive testing of the mr290 chamber, with particular emphasis on feedset breaks.Significantly we have not been able to replicate failure of the feedset tube at the chamber dome in any of our testing.The specification for the chamber requires that the feedset tube should have a breaking strain of 30 newtons.During production, pull testing of the feedset strength at both spike and dome end is performed every hour on mr290 chambers from each production line.Any chamber that fails is rejected and the whole batch is placed on hold for investigation.The user instructions that accompany the mr290 state the following: -"set appropriate ventilator alarms." -"perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

• 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: 3956411
• MDR Text Key: 4563277
• Report Number: 9611451-2014-00652
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/05/2014

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: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 041119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2014
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2004
• 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: RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT