MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY; VENTRICULAR (ASSIST) BYPASS

Model Number	1650DE
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report is being submitted for device evaluation.The battery was not returned for evaluation.Review of log files pertaining controller to revealed that the battery exhibit an abnormal high cycle count due to a communication error.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed to a communication error between the controller and battery, which may be due to a momentary disconnection on the communication pins of the controller, the controller not receiving responses from the battery, and/or due to the packet error checking method detecting bit errors.Investigation of this event is completed, and the file will be closed.If new information is received, the file will be re-opened, and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The manufacturer received product performance data due to the battery unusual/abnormal cycle count.The battery subsequently tested out of specification during manufacturer¿s analysis.The battery remains in use.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10163388
• Report Number: 3007042319-2020-03627
• Device Sequence Number: 3573316
• Product Code: DSQ
• UDI-Device Identifier: 00888707000376
• UDI-Public: 00888707000376
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: 12/31/2016
• Device Model Number: 1650DE
• Device Catalogue Number: 1650DE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1