MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CAC ADAPTOR; VENTRICULAR (ASSISST) BYPASS

Model Number	1425US
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: it was reported that the controller could not detect the ac adapter when plugged in.One (1) controller ac adapter was returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The reported event was confirmed at the bench level.Failure analysis of the device revealed that the unit passed visual inspection but failed functional testing due to an open connection within the output connector.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed to an open connection within the output connector, likely due to a manufacturing/assembly error.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.
Event or Problem Description
It was reported that the controller would continue to be powered by the battery when the controller ac adaptor was connected.The controller ac adaptor was replaced.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CAC ADAPTOR
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7134408
• Report Number: 3007042319-2017-05307
• Device Sequence Number: 19060618
• Product Code: DSQ
• UDI-Device Identifier: 00888707000093
• UDI-Public: 00888707000093
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/20/2017

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: 1425US
• Device Catalogue Number: 1425US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1