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	11/30/2017
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a patient¿s ac adapter did not provide power to the controller after having been dropped.The event was not associated with any controller alarms or pump stop events.The event was also not associated with any patient consequence and did not require medical intervention.The ac adapter was exchanged with no reported patient consequence.The site has returned the ac adapter to the manufacturer.
Additional Manufacturer Narrative
The controller ac adapter was returned for evaluation.Failure analysis of the returned device revealed that the controller ac adapter passed visual examination and functional testing.The device was able to adequately provide power to a test controller.As a result, the reported event could not be confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a patient¿s controller ac adapter did not provide power to the controller after having been dropped.The event was not associated with any controller alarms or pump stop events.The event did not require medical intervention.The controller ac adapter was exchanged.No patient complications have been reported as a result of this event.On (b)(6) 2018 it was reported that a patient¿s controller ac adapter did not provide power to the controller after having been dropped.The event was not associated with any controller alarms or pump stop events.The controller ac adapter was exchanged.No patient complications have been reported as a result of this event.

• 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: 7133294
• Report Number: 3007042319-2017-05289
• Device Sequence Number: 1119506
• Product Code: DSQ
• UDI-Device Identifier: 00888707000307
• UDI-Public: 010088870700030711170316
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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 Model Number: 1425US
• Device Catalogue Number: 1425US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 61