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

Model Number	1600US
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the battery charger was returned for evaluation.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 device revealed that passed visual inspection but during functional testing charger bay one was not charging due to faulty components cause by inductors in the charging circuit.As a result, the reported event was confirmed.Possible root cause for the reported event can be attributed to faulty components in the charging circuit.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that one of the ports of the battery charger was not charging the batteries.The battery charger was exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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 two charging ports were unable to charge a battery.Supplemental testing revealed damaged fuses, fets and diodes in the charging circuits.It was determined that the battery charger was assembled with an incorrect inductor, resulting in damaged components.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed to 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.

• 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: 7781653
• Report Number: 3007042319-2018-03726
• Device Sequence Number: 11015869
• Product Code: DSQ
• UDI-Device Identifier: 00888707000130
• UDI-Public: 00888707000130
• 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,Followup
• Report Date (Section B): 10/10/2018

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: 03/29/2018
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: 1103 VAD
• Patient Age: 53 YR