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

Model Number MR290V

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 07/28/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that the water feedset of an mr290 autofeed humidification chamber was found damaged during setup.This was observed prior to patient use.

Manufacturer Narrative

(b)(4).Method: the complaint mr290 chamber was returned to fisher & paykel healthcare in (b)(6) and was visually inspected.Results: visual inspection revealed a break in the feedset tubing approximately 480 mm from the spike connection.The feedset tubing was observed as being compressed at the point of the cut, and the edges of the cut have been sealed.A lot check revealed no other complaints of this nature for lot 131022.Conclusion: we were unable to definitively determine the cause of the feedset damage, however, due to the location of the cut, it would not have been possible for the damage to have occurred whilst the feedset was still wound on the feedset winder.We have conducted extensive testing of the mr290 chamber, with particular emphasis on feedset breaks.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.If any faults are detected the whole batch is placed on hold for investigation.Additionally all chambers are pressure tested before they leave the production line and any holes or leaks in the feedset are identified during this process.Chambers that fail any of these tests are discarded.This indicates that the feedset became damaged after distribution.The user instructions which accompany the mr290 autofeed humidification chambers 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." (b)(4).

• Brand Name: VENTED AUTOFEED 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: 4004348
• MDR Text Key: 4689780
• Report Number: 9611451-2014-00708
• 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: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• 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: 131022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2014
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2013
• 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: FISHER & PAYKEL HEALTHCARE RT200 BREATHING CIRCUIT