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

Model Number	1340
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that power module red battery was active and did not resolve.There probably was some physical damage to the unit.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
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 a red battery alarm produced on the returned power module could not be confirmed; however, the reported event of physical damage to the housing was confirmed through analysis of the returned product.The heartmate power module (serial number (b)(6)) was inspected at the service depot.The ppm underwent functional checkout and passed all tests.No yellow wrench or red battery faults were reproduced throughout testing.The power module was returned to the customer site ready for use.The root cause for the reported events was unable to be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance (qa) specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The heartmate 3 ifu (rev.D), section 7 - ¿alarms and troubleshooting¿, and heartmate 3 patient handbook (rev.A), section 5 - ¿alarms and troubleshooting¿, explain how to properly interpret and troubleshoot atypical alarms.The heartmate 3 ifu, section 3 - ¿powering the system¿, states that the power module contains an internal backup battery that provides approximately 30 minutes of backup power to the system during a power emergency.It instructs to keep the power module plugged into ac power at all times to make sure that the power module backup battery is charged and ready for use in case of power interruption.If the power module is without ac power for approximately 18 hours or more, the power module backup battery may be damaged.Additionally, it is stated that if the power module backup battery is not installed or connected when the power module is plugged in, the power module alarms, indicating that it cannot provide backup power in the event of a power interruption.The heartmate power module ifu (rev.B) (section 11.0 ¿routine maintenance¿) instructs users to bring their power module to an authorized service technician at least once per year for a thorough inspection and cleaning.Routine maintenance also includes the unit¿s internal backup battery being replaced.Heartmate 3 ifu, section 4 - ¿system monitor¿, and heartmate 3 patient handbook, section 6 - ¿caring for the equipment¿, explain how to properly handle the power module and cables to prevent damage.The patient handbook cautions the users 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: 23812538
• Report Number: 2916596-2025-07956
• Device Sequence Number: 21157038
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: (01)00813024010654(11)130101
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/25/2026

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: Health Professional
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2013
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown