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

Model Number	HMT1100
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
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 complete.
Event or Problem Description
It was reported that there was an issue with the left ventricular assist device cart, specifically with the ipad screen, which would not turn on.Upon inspection, the technician was not able to determine the root cause of the issue.Additional troubleshooting was performed, but the issue did not resolve.The screen was removed from service.
Additional Manufacturer Narrative
Section g4: there was no patient involved in this event.The pma # provided is associated with the device¿s most recent approval.Manufacturer's investigation conclusion: the reported event of screen issues on the heartmate touch (serial number: (b)(6) was confirmed via investigation of the returned tablet.The unit returned with damage to the housing.The tablet returned in a depleted state, and when it was connected to a charger, the battery indicator appeared, indicating it was charging, but when the unit attempted to boot, the screen stopped working and remained off.Information was no longer displayed on the screen, and no further troubleshooting was able to be attempted.Attempts were made to obtain additional event information, but no response was received.The root cause of the screen issue could not be conclusively determined via this analysis.The device history records were reviewed revealed no deviations with manufacturing and qa specifications.Heartmate 3 instructions for use (ifu) (rev.G) chapter 4 ¿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.Heartmate 3 instructions for use (ifu) (rev.G) 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.G) chapter 1 "introduction" informs the user to contact abbott for assistance if there are any questions after reading the manual.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: 22212523
• Report Number: 2916596-2025-03935
• Device Sequence Number: 20987584
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: (01)05415067032058(11)240823
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 10463750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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