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

Model Number MR290V

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that the water feedset tube fell off the water bag spike of an mr290 humidification chamber just after start of use.This was found prior to patient use.

Manufacturer Narrative

(b)(4).Method: the complaint mr290 chamber was returned to fisher & paykel healthcare (b)(4) and was visually inspected.Results: inspection of the complaint feedset tube and water bag spike revealed that the feedset tube was completely separated from the water bag spike.There was sufficient glue on the feedset tube but the glue had not bonded.A lot check revealed no other complaints of this nature for lot 121130.Conclusion: we were unable to determine the cause of the reported fault, although past investigations have shown that the problem has been caused by the user grasping the tube and not the spike when changing the water bag.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 or water bag spike in any of our testing.The specification for the chamber requires that the feedset tube should have a breaking strain of (b)(4) 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.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 suggests that the problem occurred after the product was released for distribution.The user instructions which accompany the mr290 chamber 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.Our monitoring and trending of complaints of loose water bag spikes on mr290 feedsets has a rate of occurrence of (b)(4) devices per (b)(4) sold worldwide in the last year to the end of april 2014.

• Brand Name: VENTED 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 3814498
• MDR Text Key: 4524836
• Report Number: 9611451-2014-00444
• 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: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• 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: 121130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2014
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2012
• 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 RT340 BREATHING CIRCUIT