MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM

Catalog Number	1435
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One controller ac adapter (b)(4) was not returned for evaluation.Analysis of the device could not be performed since the device was not returned for evaluation; hence, the event reported as "cdc not providing power" could not be confirmed.A review of the device's incoming inspection records indicated that the unit met the internal requirements prior to its quality assurance release process.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.This event was assessed and is being reported as part of a retrospective review of events, which was in response to an update to the mdr decision criteria.
Event or Problem Description
It was reported the controller dc was not providing power.The controller dc adapter was exchanged with no reported consequence or impact to the patient.No further information was provided.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6899623
• Report Number: 3007042319-2017-03398
• Device Sequence Number: 637493
• Product Code: DSQ
• UDI-Device Identifier: 00888707000109
• UDI-Public: 00888707000109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 02/25/2016

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 Catalogue Number: 1435
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR