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

Model Number	1286
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the system monitor did not respond to touch for routine parameter check.During troubleshooting, the monitor was found to operate normally.The site was advised to reboot the monitor if the issue returned or to replace the monitor if the issue continued.
Additional Manufacturer Narrative
Section d4: device lot number was not provided, and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.Section g4: there was no patient involved in this event.The pma# provided is associated with most recent approval.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of heartmate system monitor (serial # (b)(6)) not responding to touch input could not be confirmed through this analysis.Attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.Although the system monitor was not returned for evaluation, a corrective and preventative action (capa) was opened to further investigate issues related to the system monitor atypical screen behavior.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate 3 instructions for use rev c, under section f, safety checklists, replace any equipment or system component that appears damaged or worn.Under section 4, system monitor, outlines how to use the system monitor.Under ¿system monitor interface¿, ¿the system monitor¿s touch-screen interface contains menu-driven and menu-prompted operations that are accessible from six main screens.Six tabs, representing the six main screens, are continuously displayed along the top of each screen.Touching the on-screen tab allows access to the corresponding screen.Each screen has unique system functions.¿ this section includes information on the pump stop button.This section explains that if the button is released before the countdown is complete, the pump resumes at the previously set mode and speed.Under ¿alarm messages¿, all hazard and advisory alarms are outlined.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: 20215122
• Report Number: 2916596-2024-05974
• Device Sequence Number: 7328500
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142(11)190703
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Nurse
• Remedial Action: Notification
• 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: Health Professional
• 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: 08/25/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2019
• 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: FA-Q224-HF-1
• Patient Sequence Number: 1
• Patient Sex: Unknown