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

Model Number MR290V

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A hospital in the (b)(6) reported to a fisher & paykel healthcare (fph) representative that the water feedset tube detached from the bag spike on three mr290v vented autofeed humidification chambers.This was found during set up and prior to use on a patient.

Manufacturer Narrative

The complaint devices are currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: one complaint mr290 autofeed humidification chamber was returned to fisher & paykel healthcare in (b)(4) for evaluation.The chamber was visually inspected.Results: visual inspection revealed that the feedset tube had been torn in two near the bag spike connection.Sufficient glue was found at the spike and feedset tube connection and the glue bond had held.The surface at the tube break was rough, indicating that the tubing had been physically torn in two, possibly as a result of rough handling.A lot check revealed no similar complaints for lot 131001.Conclusion: the damage appears to be caused by the tube being pulled away from the spike; possibly due to the feedset being caught or put 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 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.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." (b)(4).

Event Description

A hospital in the (b)(6) reported to a fisher & paykel healthcare field representative that the water feedset tube detached from the bag spike on three mr290v vented autofeed humidification chambers.This was found during set up and prior to use on a patient.

• 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: 3678299
• MDR Text Key: 21445643
• Report Number: 9611451-2014-00222
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 02/14/2014

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: 131001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 03/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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