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	04/20/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: it was reported that the controller ac adapter was unable to provide power.One (1) controller ac adapter was returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned device revealed that the controller ac adapter passed visual examination but failed functional testing due to an intermittent connection within one of the wires of the cable's strain relief.As a result, the most likely root cause of the reported event can be attributed to wear on the strain relief, which likely contributed to the fraying or breaking of the cable wire.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 while the patient was sleeping, the controller's power source switched from the ac adapter to a battery.The patient was awaken by a low priority alarm.The clinical specialist tried solving the issue over the phone but the attempt was unsuccessful.There were no observed issues with the battery connection.The adapter was removed from service with no reported patient consequences.

• 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: 7151935
• Report Number: 3007042319-2017-05501
• Device Sequence Number: 980606
• Product Code: DSQ
• UDI-Device Identifier: 00888707000093
• UDI-Public: 00888707000093
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/28/2017

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: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1