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

Model Number	1340
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient power module (ppm) had a constant yellow wrench.The ppm was intended to be returned for evaluation.
Additional Manufacturer Narrative
A4 - patient weight not provided by customer.No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a power module alarm resulting in the yellow wrench light emitting diode (led) activating was confirmed during evaluation at the service depot of the returned power module (serial number: (b)(6)).Within a few seconds of connecting the unit to ac power, a yellow wrench alarm activated.This issue was isolated to the unit¿s backup battery.The battery was replaced, and unit was then functionally tested and found to perform as intended.Preventative maintenance was performed.The power module was returned to the customer after repairs, ready for patient use.The power module backup battery was disposed of by the service depot and no further evaluation could be performed.The root cause of the reported alarm could not be conclusively determined as the component in question could not be evaluated further.Review of the device history record for the power module, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿ covers all power module alarms and the actions to take when an alarm occurs.Heartmate 3 instructions for use 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 instructions for use section 8 explains how to care for and clean the power module and provides checklists for performing routine maintenance of the power module.The heartmate 3 patient handbook and the heartmate 3 instructions for use 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: 23417912
• Report Number: 2916596-2025-06993
• Device Sequence Number: 18399199
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: (01)00813024010654(11)130901
• 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): 01/29/2026

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?: 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: 10/21/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2013
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown