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

Model Number	1650-
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2019
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.Product event summary: the batteries were not returned for evaluation.Analysis of the log file report revealed an abnormally high cycle count recorded for batteries.The abnormal cycle count is indicative of a communication error between the battery and controller that resulted in spurious write operations of the cycle count.As a result, the reported event was confirmed.There is no evidence that the lubrication servicing was performed on the reported devices.The most likely root cause of the reported event can be attributed to a communication error between the controller and batteries.Possible root causes of the reported communication error can be attributed to momentary disconnections 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.Additional products: heartware ventricular assist system ¿ battery.Model #: 1650, catalog #: 1650, expiration date: 2017-03-31, serial#: (b)(4), udi #: (b)(4).No dev rtn to mfr? no.Mfg date:2016-03-31.Patient code(s): (b)(4), device code(s): (b)(4), fda method code(s): (b)(4), fda results code(s): (b)(4), fda conclusion code(s): (b)(4).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 abnormal cycle counts.The batteries subsequently tested out of specification during manufacturer¿s analysis.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: 9316078
• Report Number: 3007042319-2019-12496
• Device Sequence Number: 607296
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 1650-
• Device Catalogue Number: 1650-
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1