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

Model Number	HMT1100
Medical Device Problem Codes	Overheating of Device (1437); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.Patient information - no patient involvement reported.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the heartmate ipad did not turn on despite being fully charged.The ipad was able to be turned on one hour later but was warm to the touch.Later in the day, multiple attempts were made to turn on the heartmate touch ipad, but it did not turn on and function.Multiple attempts were made to restart the device with no success.
Additional Manufacturer Narrative
Section d9 correction.Manufacturer's investigation conclusion: the reported event of the screen of the heartmate touch (serial number: (b)(6)) not turning on was confirmed via investigation of the returned tablet.The reported event of the tablet being warm to the touch was not able to be confirmed.The unit returned in unremarkable physical condition, however, when the unit was powered on, it was noted that information was not being displayed as intended.The screen intermittently displayed some information, but eventually, the screen stopped working and remained off, confirming the reported event.Information was no longer displayed on the screen, and no further troubleshooting was able to be attempted.Throughout testing, the temperature of the tablet was measured, and it remained within specification for the duration of testing.No physical damage on the heartmate touch tablet was noted.The root cause 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.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the cause of the device being hotter than normal was unknown.No patient was involved.

• 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: 22523003
• Report Number: 2916596-2025-04675
• Device Sequence Number: 8058521
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: (01)05415067032058(11)211115
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/10/2025

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: 8412379
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 08/12/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/08/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• 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