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	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient had low voltage alarms while connected to the cable.Log files were submitted for review.Following review, it appeared that the log file captured 10 clusters of no external power, low power hazard, and power cable disconnect events on 14jan2026 and 15jan2026.The log file captured a no external power alarm and multiple other associated alarm types while the patient was connected to the mobile power unit (mpu).This appeared to have been caused by power to the mpu being briefly interrupted.There was no pump interruption during the events as the system controller's emergency backup battery (ebb) functioned as intended.It did not appear that the patient had been sleeping on battery power.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a no external power alarm while connected to the mobile power unit (mpu), serial number unknown, was confirmed via the submitted log files.The mpu was not returned for analysis.The analysis of the submitted log files revealed intermittent no external power alarms from 14jan2026-15jan2026, consistent with the loss of alternating current power to the mpu.The alarms occurred as a result of the bus and relative state of charge voltages within either cable steadily decreasing to approximately 0v.The backup battery supported the left ventricular assist device (lvad) as intended during the loss of external power.The loss of external power did not prevent the lvad from functioning as intended.No other notable events or alarms were observed in the log file.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no response was received.The root cause of the reported event could not be conclusively determined through this analysis.Device history records could not be reviewed due to the serial number of the mobile power unit not being reported.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 (visual and audible), including low voltage, power cable disconnect, and no external power alarms.This section also provides the actions to take if the alarm does not resolve.Heartmate 3 ifu (rev.D) section 3 ¿ ¿powering the system¿ and heartmate 3 patient handbook (rev.A) section 3 ¿ ¿powering the system¿ explains how to properly use the mpu and that in the event the mpu loses power the patient is instructed to switch power sources as the backup battery in the system controller will only temporarily power the pump.This section also cautions to plug the mobile power unit into a properly tested ac electrical outlet that is dedicated to mobile power unit use and to not use portable, multiple outlet (power strip) adapters or extension cords.Heartmate 3 patient handbook (rev.A) section 6 - ¿caring for the equipment¿ and heartmate 3 instructions for use (ifu) (rev.D) section 8 - ¿equipment storage and care¿ explain how to care for and clean all equipment, including the mpu.Heartmate 3 patient handbook (rev.A) section 10 - ¿safety checklists¿ and heartmate 3 instructions for use (ifu) (rev.D) section e - ¿safety checklists¿ provide the user with checklists to assist the patient in performing routine maintenance of all components of the heartmate 3 left ventricular assist device, including the mpu.The 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: 24214016
• Report Number: 2916596-2026-00403
• Device Sequence Number: 12811238
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: (01)00813024010883
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 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
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American