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	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that heartmate touch screen was blank.It was charged all evening.There was something on as the screen lit up and the noise when the screen was locked still occurred, but the screen was blank.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the heartmate touch tablet having a blank display was confirmed during evaluation of the returned product (serial number: (b)(6)).The returned heartmate touch was connected to a test laboratory charger, and it was noted that the display remained blank.When pressing the power button, the tablet emitted sounds consistent with waking/putting the device to sleep; however, the screen remained blank.The reported event was determined to be related to an issue with the tablet hardware and/or software; however, the specific root cause of the observed issue could not be conclusively determined through this analysis.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The abbott heartmate 3 instructions for use with heartmate touch (rev.D) and abbott heartmate 3 left ventricular assist system patient handbook (rev.A) are currently available.Chapter 4 of the ifu ¿heartmate touch communication system¿ and the heartmate touch communication system quick start guide (rev.B) explain the operation of the heartmate touch system, including how to set up the heartmate touch communication system for use and how to turn on the tablet.The user is instructed to fully charge the heartmate touch tablet or plug in the power cable during set-up.Section 6 of the ifu describes how to care for, store, and clean all equipment, including the heartmate touch tablet.Chapter 1 of the ifu informs the user to contact abbott for assistance if there are any questions after reading the manual.Appendix b of the ifu states to use only the abbott medical 0 supplied 2-meter (80 in.) usb to lightning cable to power on or charge the tablet.Chapter 8 of the ifu indicates that battery life varies by use and configuration.The user is instructed to see www.Apple.Com/batteries for more information.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.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: 21744131
• Report Number: 2916596-2025-01877
• Device Sequence Number: 18342338
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: (01)05415067032058(10)7622496
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/30/2025

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: 7622496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2020
• 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