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	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the mobile power unit (mpu) unexpectedly shutting off and not turning back on was unable to be confirmed through this analysis.No product was returned for evaluation and no log files were submitted for review.The root cause of the reported event was unable to be conclusively determined through this investigation.The heartmate 3 left ventricular assist device (lvas) instructions for use (ifu), and the heartmate 3 patient handbook, are currently available.The current revision of ifu and patient handbook can be found on the eifu page of the abbott website.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.The heartmate 3 ifu section 8, entitled ¿equipment storage and care¿, instructs the user how to care for and clean all equipment, including the mobile power unit (mpu).The heartmate 3 patient handbook (section titled "emergency contact list") cautions 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 relevant sections of the device history records for the mobile power unit (mpu) (serial number (b)(6) 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 was at home utilizing the mobile power unit (mpu) and the unit turned off.It was brought to the hospital for evaluation and could not be corrected.A new power cord was tried along with several outlets.The mpu had a v-lock connector on the ac power cord.The patient was given a new mpu.The mpu had a v-lock connector and the ac power cord did not come loose.The old mpu was not returned.

• 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: 24120922
• Report Number: 2916596-2026-00377
• Device Sequence Number: 15831627
• Product Code: DSQ
• UDI-Device Identifier: 05415067038234
• UDI-Public: (01)05415067038234(11)230216
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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: 8872383
• 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: 01/13/2026
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 105 KG