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

Model Number MR290V

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that the feedset of two mr290 humidification chambers were found cut.This was found prior to patient use.

Manufacturer Narrative

(b)(4).Method: the two complaint mr290 autofeed humidification chambers were returned to fisher & paykel healthcare in (b)(4) for evaluation and were visually inspected.These devices were from lot number 130926, manufacture date 26 september 2013 and lot number 131007, manufacture date 7 october 2013.Results: the visual inspection revealed a break in the feedset tube at the connection to the chamber dome of both chambers.The surface at the break was rough (not smoothly cut).A lot check revealed no other complaints for lot 130926 and two other complaints for lot 131007.Conclusion: we were unable to determine what caused the reported damage.However the damage appears to be the result of the tube being pulled away from the dome, possibly due to the feedset being caught or under tension.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 (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.If any product fails this test, 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 suggests that the damage occurred after the product was released for distribution.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 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: 3723262
• MDR Text Key: 16059282
• Report Number: 9611451-2014-00235
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/13/2014

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: 130926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2013
• 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 RT200 BREATHING CIRCUIT