MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, MOBILE POWER UNIT, N/A; Ventricular (assist) bypass

Model Number	107754
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the mobile power unit (mpu) not functioning as expected was not confirmed.The mpu, serial number (b)(6), was not returned for analysis.Reported information stated the mpu would not power on after the patient tested it on three different outlets.The patient was able to get the mpu to turn on and brought it in for replacement.A warranty replacement was requested and a new mpu was given to the patient.The mpu was tested and was working as expected and passed testing.The root cause of the reported event could not be conclusively determined through this analysis.The current revisions of the instructions for use (ifu) and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 left ventricular assist system (lvas) ifu, and the heartmate 3 patient handbook, are currently available.The heartmate 3 patient handbook section 3 ¿powering the system¿ and the heartmate 3 lvas ifu section 3 ¿powering the system¿ instructs users on how to properly power on the mpu.Heartmate 3 patient handbook caution users to call their hospital contact 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 relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient's mobile power unit (mpu) would not power up on three different outlets at home and after checking power cables.The patient was able to get it to turn on and brought it in for replacement as the patient was afraid to continue to use it.The mpu was tested and was working fine, passed self-tests and looked fine but the patient did not want it back.The mpu had a v-lock connector on the ac power cord.A new mpu was given to the patient.

• 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: 24270781
• Report Number: 2916596-2026-00747
• Device Sequence Number: 18672154
• Product Code: DSQ
• UDI-Device Identifier: 05415067038234
• UDI-Public: (01)05415067038234(11)250621
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: 10899312
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2025
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 121 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White