MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER; 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	05/09/2018
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.Concomitant medical products: 1103 vad implanted: (b)(6) 2017, dtba1q1 icd implanted: (b)(6) 2016, 429888 lead implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the controller ac adapter did not provide power and the green light did not illuminate.The controller ac adapter will be exchanged.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.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned device revealed that the unit passed visual inspection and functional testing.As a result the reported event could not be confirmed.Based on the investigation conducted, possible causes of the reported event can be attributed to multiple factors, including but not limited to, a marginal connection between the controller ac adapter and the wall power outlet, and/or a marginal connection between the controller ac adapter and the controller.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The controller ac adapter was exchanged.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7570537
• Report Number: 3007042319-2018-02238
• Device Sequence Number: 1759246
• Product Code: DSQ
• UDI-Device Identifier: 00888707000307
• UDI-Public: 00888707000307
• 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,Followup
• Report Date (Section B): 08/23/2018

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: 04/06/2018
• Device Model Number: 1425US
• Device Catalogue Number: 1425US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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: 694765 LEAD, 5076-52 LEAD
• Patient Age: 49 YR
• Patient Weight: 62