MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER AC ADAPTER; CIRCULATORY ASSIST SYSTEM

Catalog Number	1403US
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the controller alternating current (cac) adapter would not provide power to the controller even though the light on the junction box was green.It was noted that there was no known damaged to the adapter.The cac adapter was exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
One cac adapter, (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 device revealed that the controller ac adapter failed visual examination due to a to a tear on the output cable most likely due to the handling of the device.The controller ac adapter also failed functional testing as the device was not able to adequately establish a connection and provide power to a controller.The most likely root cause of the reported event can be attributed to an open circuit along the output cable or output connector.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER AC ADAPTER
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6868726
• Report Number: 3007042319-2017-03155
• Device Sequence Number: 16340556
• Product Code: DSQ
• UDI-Device Identifier: 00888707000093
• UDI-Public: 0100888707000093
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/30/2014
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/21/2017; 10/24/2018
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 11/14/2017; 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 72