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

Model Number	107754
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced multiple losses of external power that was suspected by clinicians to be due to user error.The patient was provided reeducation and log files were submitted for review.The log file captured intermittent no external power alarm(s) and multiple other associated alarm types between (b)(6) 2025 and (b)(6) 2025.This was caused by power to the mobile power unit (mpu) being briefly interrupted.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a no external power alarm while connected to the mobile power unit (mpu) was confirmed via the submitted log files.A review of the submitted controller event log file spanned approximately 4 days (07dec2025 ¿ 10dec2025 per time stamp).On 07dec2025 at 01:16:51, 09:41:07, 15:43:54, and 10dec2025 at 09:24:29 and 09:27:21, the no external power alarm activated while connected to the mobile power unit (mpu) due to both white and black lead voltages dropping to ~1v.This was consistent with a loss of ac power.The alarm cleared on its own each time shortly after power was restored.The backup battery was able to provide power to the controller during this event.The alarm did not affect the controller's ability to operate the pump at the set speed.There were no other notable alarms active in the log file.The mpu, serial (b)(6), was not returned for analysis.A root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.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.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 section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5-¿alarms and troubleshooting¿ explain how to troubleshoot the system controller, including no external power alarms.The "patient care management" section of the ifu instructs the patient to keep a flashlight, fully-charged batteries, and battery clips within reach to be prepared for a power outage.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was later stated that the loss of power event was suspected to be due to the patient unplugging their mpu cable from the wall while tethered, but the patient's memory was limited.The mpu had a v-lock connector on the ac power cord.It was unknown if the ac power cord came loose at the wall outlet or from the back of the unit.It was unknown if there were any environmental circumstances that would have affected ac power at the time of the event.The mpu was not exchanged or removed from service.

• Brand Name: HEARTMATE®, MOBILE POWER UNIT, 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: 23915461
• Report Number: 2916596-2025-08299
• Device Sequence Number: 15958599
• Product Code: DSQ
• UDI-Device Identifier: 05415067038234
• UDI-Public: (01)05415067038234(11)240126
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: 107754
• Device Catalogue Number: 107754
• Device Lot Number: 10174933
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White