MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0; VENTRICULAR (ASSIST) BYPASS

Model Number	1403US
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2017
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 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.Product event summary: the controller was not returned for evaluation.The event file revealed controller power up event(s).As a result, the reported event was confirmed.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on both power sources.An internal investigation was initiated to capture events involving the controller losing power.This event was assessed and is being reported as part of a retrospective review of log file data.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported after log file review that the controller experienced loss of power event(s).The controller remains in use.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8939588
• Report Number: 3007042319-2019-10513
• Device Sequence Number: 2584964
• Product Code: DSQ
• UDI-Device Identifier: 00888707000116
• UDI-Public: 00888707000116
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

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: 12/31/2017
• Device Model Number: 1403US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 - VAD