MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE® POWER MODULE (N/A); VENTRICULAR (ASSIST) BYPASS

Model Number	1340
Medical Device Problem Codes	Failure to Interrogate (1332); Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the backup battery wasn't recognized when connected.It also appeared that the power module (pm) was dropped and the case was cracked.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported events of an alarm activating when connecting the power module backup battery and damage to the power module housing were not confirmed as no products were returned for analysis.Provided information indicated that the power module would be returned for analysis; however, no products have been returned to date.Multiple attempts were made to obtain additional information, including if a tracking number for the returning product was available; however, no response was received.This file will be reopened with further analysis if any products are returned at a later date.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the heartmate power module, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The power module was shipped to the customer on 11oct2011.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 ifu (rev.D) section 7 ¿ ¿alarms and troubleshooting¿ cover all power module alarms and the actions to take when an alarm occurs.Heartmate 3 ifu (rev.D) section 3 ¿ "powering the system" explains how to set up the power module for use, including how to install the power module backup battery, and how to use the power module.Heartmate 3 patient handbook (rev.A) section 6 ¿ ¿caring for the equipment¿ explains how to care for and clean all equipment, including the power module.Additionally, section 10 ¿ ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of the heartmate 3 lvad equipment, including the power module.The heartmate 3 patient handbook (rev.A) and the heartmate 3 ifu (rev.D) caution the user 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE® POWER MODULE (N/A)
• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23649354
• Report Number: 2916596-2025-07588
• Device Sequence Number: 10054860
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: (01)00813024010654(11)110930
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: Lay User/Patient
• Device Model Number: 1340
• Device Catalogue Number: 1340
• Was Device Available for Evaluation?: No
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2011
• 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