MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM - CDC ADAPTER; CIRCULATORY ASSIST SYSTEM

Catalog Number	1435
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported no power with the returned cdc adapter was not confirmed.Various analyses were conducted and reviewed in order to evaluate the performance of the cdc adapter in relation to the reported event.Analysis of the cdc adapter revealed that the device failed to meet specifications; the device passed visual inspection but failed functional testing as a result of the connector plug found not connecting as intended and requiring extra force to successfully connect the adapter to the controller.This observation is considered not related to the reported event.The reported event could not be duplicated at the bench level; the cdc adapter was able to provide power to the controller successfully.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.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.
Event or Problem Description
During a clinic visit, it was reported by the patient that the controller dc adapter was not providing power.The patient also stated that the dc in the car worked to power other items.The controller dc adapter was replaced with no reported consequence or impact to the patient.No further information was provided.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM - CDC ADAPTER
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6921217
• Report Number: 3007042319-2017-03570
• Device Sequence Number: 852215
• Product Code: DSQ
• UDI-Device Identifier: 00888707000109
• UDI-Public: 00888707000109
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2016

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 Catalogue Number: 1435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 79