MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER; VENTRICULAR (ASSIST) BYPASS

Model Number	1430US
Medical Device Problem Codes	Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2019
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 and destination therapy 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient¿s controller ac adapter does not provide power to the controller.It was further reported that the light and power on the ac adapter was going on and off.The controller ac adapter was replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the controller ac adapter was returned for evaluation.Failure analysis of the returned device revealed that the device passed visual examination and functional testing.The controller ac adapter was able to adequately provide power to a test controller.The reported controller ac adapter power turning on and off cannot be confirmed as the device performed as intended without any anomalies.As a result, the reported event could not be confirmed or duplicated during testing.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: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8228354
• Report Number: 3007042319-2019-00097
• Device Sequence Number: 13851168
• Product Code: DSQ
• UDI-Device Identifier: 00888707002738
• UDI-Public: 00888707002738
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 05/31/2019
• Device Model Number: 1430US
• Device Catalogue Number: 1430US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR