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

Model Number	1521
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted as part of remediation activities associated with capa#: 643143, which is addressing mdr reporting guidance from fdas 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.Product event summary: the monitor (b)(6) 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 monitor revealed that the device passed visual inspection.Functional testing revealed that the logs obtained from the monitor were unable to be used to create an autologs report.It was determined that the monitor contained an updated software version which embeds a text string in the downloaded log files, which prevents the autologs system from creating an autologs report.This observation did not interfere with the functionality of the monitor or the information recorded within the log files.As a result, the reported event was confirmed.Based on the investigation conducted, the most likely root cause of the reported event can be attributed to a monitor software version that is incompatible with autologs.Capa: pr00617627 is investigating this issue.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the monitor was not working.The site attempted to download logfiles from several controllers and several usbs to the monitor, but a data transfer error occurred each time.After downloading the log files to the monitor, a usb was attached and the logfiles were downloaded from the monitor to the usb.When attempting to submit logfiles the site received an error that the files could not be processed.An attempt was made to delete the logfiles from the usb but that showed an error that the files were "write only".The monitor was removed from service.There was no patient involvement.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - MONITOR
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 22330460
• Report Number: 3007042319-2025-01363
• Device Sequence Number: 8301078
• Product Code: DSQ
• UDI-Device Identifier: 00888707009256
• UDI-Public: (01)00888707009256(11)211216
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: 1521
• Device Catalogue Number: 1521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1993-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown