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

Model Number	1600US
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
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 battery charger was returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.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 returned battery charger revealed that the unit passed visual inspection.Functional testing revealed that led status indicators on bay 3 and 4 were inoperable.Supplemental testing revealed damaged leds.It was determined that the battery charger was assembled with an incorrect inductor, damaging the led indicators.As a result, the reported "not charging" and "flashing yellow" event could not be confirmed.However, the damaged led was most likely perceived by the patient as the reported not charging.The most likely root cause of the reported event can be attributed improper assembly.An internal investigation was initiated to investigate battery chargers assembled with incorrect inductors.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported, by product analysis,that the incorrect inductor was used during the assembly process.The battery charger was exchange.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY CHARGER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7995468
• Report Number: 3007042319-2018-04968
• Device Sequence Number: 1104821
• Product Code: DSQ
• UDI-Device Identifier: 00888707000130
• UDI-Public: 00888707000130
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/23/2018

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: 1600US
• Device Catalogue Number: 1600US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MCS VAD
• Patient Age: 71 YR
• Patient Weight: 97