MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, SYSTEM MONITOR; VENTRICULAR (ASSIST) BYPASS

Model Number	1286
Medical Device Problem Code	Application Program Version or Upgrade Problem (2881)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that system monitor was showing message on screen previous software upgrade was incomplete insert software card in memory slot and touch screen to continue.Turn monitors off, unplugged from power module.The system monitor was turned off and unplugged from power module.Then, it was plugged back into power module and powered back on.It was advised to remove the system monitor from service.
Additional Manufacturer Narrative
Section d4: expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Section h8: corrected.Manufacturer's investigation conclusion: the reported event of a software upgrade issue was unable to be confirmed.The system monitor (serial number: (b)(6)) was not returned for analysis and no images were submitted for review.Multiple good faith efforts were sent asking if the system monitor was rebooted, and if the issue was resolved.To date, no response has been provided.A root cause for the reported event was unable to be conclusively determined through this investigation.The device history records were reviewed, and the records revealed the heartmate system monitor (serial number: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.Setup and use of the system monitor with the heartmate power module are documented in the heartmate power module instructions for use (ifu) section titled ¿setting up the system monitor for use with the power module¿.Handling precautions when the system monitor is mounted on the power module are documented in the power module ifu.Per the power module ifu (section 9.0 ¿routine maintenance¿), users are instructed to regularly inspect the equipment for damaged pins and connectors, including the system monitor, and to obtain replacements if necessary.Per the power module ifu, if the system monitor does not function properly, contact the company's technical service department.Heartmate 3 instructions for use section 4 - ¿system monitor¿ explains how to properly interpret and troubleshoot system monitor error messages.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE®, SYSTEM MONITOR
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20193468
• Report Number: 2916596-2024-05879
• Device Sequence Number: 6815292
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 1286
• Device Catalogue Number: 1286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2013
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown