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

Model Number 1600GB

Device Problems Smoking (1585); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac trans plantation 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.Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the battery charger "exploded with smoke" and exhibited "some hissing" sound while charging batteries.The battery charger will be replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.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 revealed that the returned battery charger passed visual inspection.Functional testing revealed a "hissing sound".The battery charger was not able to power up or charge as expected.Internal inspection revealed damage on the power supply module which likely caused the damaged also observed on a fuse, capacitor, resistors, fet transistor.Additionally, an area on the power supply felt warm to the touch.The battery charger regained functionality once the power supply was replaced.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed to a faulty power supply module.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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Newly received information indicated that the battery charger model # was 1600gb.Model # updated from 1610gb to 1600gb, catalog # updated from 1610gb to 1600gb, expiration date updated to 30-aug-2012, and unique identifier updated from (b)(4) to asku.Device manufacture date updated to 30-aug-2011.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY CHARGER
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 10251357
• MDR Text Key: 198133726
• Report Number: 3007042319-2020-04329
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2012
• Device Model Number: 1600GB
• Device Catalogue Number: 1600GB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MCS UNKNOWN VAD.; MCS UNKNOWN VAD
• Patient Weight: 77