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

Model Number	1430DE
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2015
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 in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the device revealed that the unit passed visual inspection but failed functional testing due to an open input fuse.The open fuse prevented the controller ac adapter from providing power, confirming the reported event.The most likely root cause of the reported event can be attributed to an open fuse, due to a combination of a reduced fuse in-rush current rating along with the absence of a current-limiting thermistor.An internal investigation evaluated open input fuses associated with controller ac adapters, catalog number 1430xx.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 patient's ac adapter was not providing power to the controller.It was mentioned that the metal clamp was removed to re-establish a connection but the action was unsuccessful.The adapter was exchanged 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: 7152695
• Report Number: 3007042319-2017-05509
• Device Sequence Number: 1276777
• Product Code: DSQ
• UDI-Device Identifier: 00888707000093
• UDI-Public: 00888707000093
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: 1430DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• 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