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

Model Number	107754
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced a mobile power unit (mpu) alarm.The patient reported that they had it plugged into a surge protector versus a direct wall outlet.No log files were available.The patient was told to wear batteries at night until mpu was evaluated and repaired.The patient was provided a loaner mpu.
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 an atypical alarm occurring while connected to the mobile power unit (mpu) was not confirmed.Additional information provided communicated that no log files were available for review and that no products would be returned for analysis.It was also noted that it was not known if the mpu has a v-lock connector on the ac power cord, or if the ac power cord became disconnected from the back of the unit or from the back on the unit.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 mobile power unit (mpu), serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The mpu was shipped to the customer on 07jul2023.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¿ and heartmate 3 patient handbook (rev.A) section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (auditory and visual), and the actions to take if the issue does not resolve.Heartmate 3 ifu (rev.D) section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook (rev.A) section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment, including the system controller power cables.Additionally, heartmate 3 patient handbook section 10 entitled ¿safety checklists¿, instructs users to regularly inspect their accessories ¿ including their mobile power unit ¿ for damage, and to replace any equipment that appears damaged or worn.Patient handbook and the ifu 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®, 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: 24306465
• Report Number: 2916596-2026-00656
• Device Sequence Number: 5381059
• Product Code: DSQ
• UDI-Device Identifier: 05415067038234
• UDI-Public: (01)05415067038234(11)230407
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 02/16/2026

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: 107754
• Device Catalogue Number: 107754
• Device Lot Number: 8974572
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2023
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White