MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE TOUCH¿; VENTRICULAR (ASSIST) BYPASS

Model Number	HMT1100
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: device manufacture date cannot be determined.The primary udi number in d4 is updated with all of the current information available.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the heartmate touch (hmt) screen froze and duplicated images.The site restarted the hmt and issues continued.The center requested a replacement hmt.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of issues with the heartmate touch screen was confirmed.Evaluation of the returned heartmate touch tablet (serial number: (b)(6) revealed that a horizontal portion of the middle of the screen was darkened.The darkened portion of the display was observed on all screens/applications on the tablet during testing.The heartmate touch app was functionally tested with a test wireless adapter and system controller on a mock circulatory loop and was found to operate as intended during analysis.The display issue did not prevent information from being read from the screen and did not affect the functionality of the heartmate touch tablet or app.No other issues were observed.No physical damage to the heartmate touch tablet was observed during testing.The root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate 3 instructions for use (ifu) (rev.B) chapter "equipment storage and care" describe how to care for, store, and clean all equipment, including the heartmate touch tablet.Heartmate 3 instructions for use (ifu) (rev.B) chapter 1 "introduction" informs the user to contact abbott for assistance if there are any questions after reading the manual.Heartmate 3 instructions for use (ifu) (rev.B) chapter 4 ¿heartmate touch communication system¿ and the heartmate touch communication system quick start guide (rev.B) under ¿how to use the heartmate touch communication system¿ explain the operation of the heartmate touch system.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE TOUCH¿
• 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: 20741190
• Report Number: 2916596-2024-07409
• Device Sequence Number: 8297484
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: (01)05415067032058
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/09/2025

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: HMT1100
• Device Catalogue Number: HMT1100
• Device Lot Number: 8771577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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