MAUDE Adverse Event Report: HEARTWARE HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0; CIRCULATORY ASSIST SYSTEM

Catalog Number 1407DE

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported that the screen on the controller went black.  the controller was exchanged.  no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary #controller (b)(4) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned controller revealed that the device passed visual examination.Functional testing revealed an inability to start the controller (b)(4).Supplemental testing revealed that a fairchild metal¿oxide¿semiconductor field-effect transistor (mosfet) on the power board was found shorted, which subsequently caused the controller to lose functionality.The mosfet was replaced with a known working mosfet transistor and the results revealed that the controller was able start and functioned as expected.Review of log files revealed a controller power up event on (b)(6), 2017 at 09:40:51.The data point prior to the controller power up event, at 09:40:06, revealed that an active ac adaptor was connected to power port 1 and (b)(4) was connected to power port 2 with 65% relative state of charge (rsoc).A vad disconnect alarm was logged at 09:40:52 and was cleared at 09:40:53.A second controller power up event was logged at 09:41:01.The most likely root cause of the reported event of "screen on the controller went black" can be attributed to a shorted fairchild mosfet.A supplier investigation has been open to evaluate shorted fairchild mosfet transistor on the power board.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6810882
• MDR Text Key: 83749420
• Report Number: 3007042319-2017-02764
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 90