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

Model Number MR290V

Device Problem Detachment Of Device Component (1104)

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

Event Date 03/20/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that an mr290 humidification chamber feedset has disconnected from the chamber dome after one day of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr290 autofeed humidification chamber was returned to fisher & paykel healthcare in (b)(4) for evaluation.Results: visual inspection revealed the feedset tubing was separated at the connection to the chamber dome.Glue was found around the feedset and the feedset port in the chamber dome.A lot check revealed one other complaint of a similar nature for the lot number provided.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 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.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 hospital reported that the subject mr290 chamber was in use for a day before the damage was observed, which indicates that the chamber became damaged during use.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: 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: 3754843
• MDR Text Key: 4481774
• Report Number: 9611451-2014-00346
• 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: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• 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: 130519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2014
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2013
• 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