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

Model Number MR290V

Device Problem Disconnection (1171)

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

Event Date 06/13/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that they found disconnection between the bag spike and water feedset tube of an mr290 humidification chamber after three days of use.No patient consequence was reported.

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 tubing was completely separated from the spike.There was sufficient glue present on both components.Conclusion: the product had performed successfully for three days, which suggests that the detaching of the spike may have occurred as a result of pulling on the tube instead of 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 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.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.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 (b)(6).

• 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: 3903960
• MDR Text Key: 4429592
• Report Number: 9611451-2014-00582
• 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: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• 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: 1306100105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2014
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• 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