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

Model Number	1435-
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: it was reported the controller dc adapter would no longer provide power to the controller.The controller dc adapter was returned for evaluation.The device associated with this complaint was initially returned to the product analysis lab on 12/121/2015, but remains unaccounted for.An investigation was opened to determine the whereabouts of the device.As a result, the reported event could not be confirmed because the device is unavailable for analysis.A review of documentation records confirmed that the associated device met all requirements for release.Applicable risk documentation and experience with events similar circumstances were considered.A possible root cause of the inability of the controller dc adapter to provide power may be attributed, but not limited to an open circuit along the output cable or output connector.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.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 controller dc adapter was no longer providing power to the controller.The controller dc adapter was taken out of service and replaced.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER DC ADAPTER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7150425
• Report Number: 3007042319-2017-05479
• Device Sequence Number: 933257
• Product Code: DSQ
• UDI-Device Identifier: 00888707000109
• UDI-Public: 00888707000109
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2017

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 Model Number: 1435-
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1