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)
Date of Event	06/13/2018
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 passed external visual inspection, functional testing revealed port one (1) not charging with multiple component failure in the charging circuit and ready status led component in led power supply circuit due to inductors.Bay four (4) status led was defective due to inductors in the led power supply circuit.Investigation is ongoing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the battery charger was not charging on a single port.Product analysis indicated that an incorrect inductor was used in the assembly process.The battery charger was exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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.The battery charger bch097325 passed external visual inspection.Functional testing revealed that charging port 1 was unable to charge a battery.Supplemental testing revealed a damaged fuse, fet and diode in the charging circuit and a power led indicator was inoperable due to defective diode in the led status charging circuit.Functional testing also revealed that an led status indicator in port 4 was inoperable; supplemental testing revealed a damaged led.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: 7798324
• Report Number: 3007042319-2018-03913
• Device Sequence Number: 228133
• Product Code: DSQ
• UDI-Device Identifier: 00888707000130
• UDI-Public: 00888707000130
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/12/2018

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: 06/25/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/12/2018
• 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: 34 YR
• Patient Weight: 110