MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, SYSTEM MONITOR; Ventricular (assist) bypass

Model Number	1286A-US
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a display issue regarding the system monitor was confirmed.The system monitor (serial number (b)(6)) was not returned for analysis.However, an image of the monitor was provided, and glitched/misaligned numbers were observed on the monitor¿s screen.Per additional information, the monitor was rebooted and the issue resolved.The root cause of the reported event was unable to be conclusively determined through this analysis.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.The device is included in the system monitor atypical screen behavior advisory issued by abbott on 08 may 2024.The reported event and subsequent investigation do not indicate an issue with the manufacture of the product.Setup and use of the system monitor with the heartmate power module are documented in the heartmate power module instructions for use (ifu) (rev.B, section titled ¿setting up the system monitor for use with the power module¿).If issues occur and the outlined troubleshooting steps do not resolve the issue, contact abbott for assistance.Handling precautions when the system monitor is mounted on the power module are documented in the power module ifu (rev.B).No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the system monitor was showing incorrect numbers while connected to the patient.The system monitor also froze.The system monitor was turned off then back on.The issue resolved after restarting the system monitor.

• 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: 19492845
• Report Number: 2916596-2024-03718
• Device Sequence Number: 8558821
• Product Code: DSQ
• UDI-Device Identifier: 00813024010852
• UDI-Public: (01)00813024010852(11)111101
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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: 1286A-US
• Device Catalogue Number: 1286A-US
• Device Lot Number: 109987
• 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: 05/08/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2011
• 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 Age: 15 YR
• Patient Sex: Male
• Patient Weight: 41 KG