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

Model Number MR290V

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2014

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare field representative that the water feedset of three mr290 autofeed humidification chambers became detached from the water bag spike.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the three complaint devices were not returned to fisher & paykel healthcare in (b)(4).The complaint devices were disposed by the hospital.Therefore, our investigation is based on the information provided by the hospital and our knowledge of the product.The hospital reported that the water feedset tube of three mr290v vented autofeed humidification chambers had disconnected from the water bag spike.Two of the chambers had lot date 131013 (13 october 2013) and no lot date was provided for the third chamber.Without the return of the complaint devices we are unable to determine what may have caused the problem experienced by the customer.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 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.If any product fails this test, the whole batch is placed on hold for investigation.The healthcare facility reported that the complaint chambers were in use when the damage was observed, which indicates that the water feedsets became damaged during use.No patient consequence was reported.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.".

• 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: 3756060
• MDR Text Key: 4555103
• Report Number: 9611451-2014-00352
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• 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: 131013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1