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

Model Number	L1286INT
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section g3: there was no patient involved in this event.The pma# provided is associated with most recent approval.Manufacturer's investigation conclusion: the reported event of a distorted display of the system monitor when booting up was confirmed and reproduced.The system monitor, serial (b)(6), was returned for analysis.When the unit was connected to power, it booted up and showed some distorted graphics.The text displaying ¿heartmate¿ and the software version was distorted intermittently.Rebooting the monitor did not resolve the issue.The unit was opened and investigated, and no anomalies were found.The issue resolved after the compact flash card was reseated.The system monitor was then run for several hours without issue.The provided information stated that rebooting the system monitor did not solve the issue.A root cause for the reported event was not 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 history records were reviewed were reviewed and showed no deviations from manufacturing or qa specifications.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Heartmate 3 instructions for use (rev.B) section 4-¿system monitor¿ explains how to properly interpret and troubleshoot system monitor communication issues and error messages.Heartmate 3 instructions for use (rev.B) section 4-¿system monitor¿ and heartmate 3 patient handbook (rev.G) section 6-¿caring for the equipment¿ explain how to properly handle the monitor to prevent damage.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that when switching on the system monitor, the display did not boot correctly.Rebooting the system monitor did not solve the issue.The display showed either just colored pixels or blurred lines.The system monitor was exchanged.

• Brand Name: HEARTMATE SYSTEM MONITOR, OUS
• 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: 21240706
• Report Number: 2916596-2025-00580
• Device Sequence Number: 8533199
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142(11)060424
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

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: Health Professional
• Device Model Number: L1286INT
• Device Catalogue Number: L1286INT
• 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: 01/16/2025
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2006
• 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