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

Model Number MR290V

Device Problem Filling Problem (1233)

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

Event Date 02/06/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint mr290v vented humidification chambers were returned to fisher & paykel healthcare in (b)(4) where they were visually inspected.Results: visual inspection of one of the returned chambers revealed a break in the feedset tube at the connection to the chamber dome.The surface of the break was rough (not smoothly cut).Visual inspection of the other mr290 chamber revealed a break in the feedset tube at the connection to the bag spike.The surface of the break was rough (not smoothly cut).A lot check revealed one other complaint of this nature for lot 130716.Conclusion: the damage observed on the returned mr290v vented autofeed humidification chambers was most likely caused by the feedset tube being pulled away from the chamber, possibly due to the feedset tube 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.(b)(4).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.Any chamber that fails is rejected and the whole batch is placed on hold for investigation.All chambers are pressure tested before they leave the production line and any holes or leaks in the feedset are identified during this process.Any chamber that fails is rejected.This suggests that the damage to the feedset tubes occurred after the chambers were 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.".

Event Description

A hospital in (b)(6) reported that two mr290v vented autofeed humidification chambers do not fill up.This was found prior to patient use.

• Brand Name: VENTED AUTOFEED 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: 3676230
• MDR Text Key: 18768866
• Report Number: 9611451-2014-00218
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/11/2014

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: 1307160306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2013
• 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: RT200 ADULT BREATHING CIRCUIT