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

Model Number	107754
Medical Device Problem Codes	Disconnection (1171); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's mobile power unit (mpu) had been alarming the past few nights.Log files were sent for review.The log files captured no external power alarms and multiple other associated alarm types on 26dec2025 and 27dec2025.This was caused by interruption of power to the mpu.There were random power cable disconnects on 29dec2025 while connected to the mpu associated with the black lead.The alarm silence button was repeatedly activated on 31dec2025 between 11:07 and 11:16 but no alarms at these times.These occurred while the patient was connected to the mpu.It was communicated on 09jan2026 that there were no environmental circumstances that would have affected ac power at the time of the event.The no external power alarms had resolved after the patient switched outlets.
Additional Manufacturer Narrative
Section d4: device serial number was not provided, manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of no external power alarms was confirmed via the submitted log files.On 26dec2025 and 27dec2025, multiple power cable disconnect, low voltage hazard, and no external power alarms were captured while connected to the mpu due to losses of ac power.The alarms resolved each time power was restored to the system.The backup battery supported the system without issue during these events.The pump operated as intended and there were no other notable events captured in the log file.The provided information indicated the mpu had a v-lock connector, it is unknown if the ac power cord came loose from the back of the unit or the wall outlet, there were no environmental circumstances that would have impacted ac power at the time of the reported event, the mpu was not exchanged, and the alarms resolved after the patient switched outlets.A root cause for the reported event was not conclusively determined through this analysis.The device history records were reviewed and the records reveal that the heartmate mobile power unit, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The current revision of the instructions for use (ifu) and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu heartmate 3 patient handbook, document are currently available.Section 7 of the ifu, entitled ¿alarms and troubleshooting¿, provides instructions on how to interpret and troubleshoot power cable disconnect, low voltage hazard, and no external power alarms.Section 3 of the ifu, entitled ¿powering the system¿, instructs the user to transfer from the mobile power unit (mpu) to another power source should there be a power failure.The system controller¿s backup battery will temporarily support the pump while transferring.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®, 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: 24110100
• Report Number: 2916596-2026-00158
• Device Sequence Number: 10400196
• Product Code: DSQ
• UDI-Device Identifier: 05415067038234
• UDI-Public: (01)05415067038234(11)250222
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/28/2026

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: 10709143
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2025
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White