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

Model Number	L103868
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1-a4: there was no patient involved.Section d4: manufacture date (h4) will be provided upon investigation.The primary udi number in d4 is reflective of all available information.Section g3: there was no patient involved in this event.The pma# provided is associated with most recent approval.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 during routine preventative maintenance the indicators on the power module (pm) were not lighting when the pm was plugged in.The power cable was changed, and the issue persisted.The power cable functioned when testing with a different pm on the same outlet.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the power module light emitting diode (led) indicators not working was not confirmed.The power module (serial: (b)(6)) was not returned for testing.Provided information from the customer reported a different power cable was used, and the issue persisted.The old power cable was able to operate a different power module without issue.A root cause for the reported event could not be conclusively determined through this investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The reported event of the power module light emitting diode (led) indicators not working was not confirmed.The power module (serial: (b)(6)) was not returned for testing.Provided information from the customer reported a different power cable was used, and the issue persisted.The old power cable was able to operate a different power module without issue.A root cause for the reported event could not be conclusively determined through this investigation.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE® POWER MODULE (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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23577909
• Report Number: 2916596-2025-07197
• Device Sequence Number: 18488957
• Product Code: DSQ
• UDI-Device Identifier: 05415067039545
• UDI-Public: (01)05415067039545(11)240829
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: Health Professional
• Device Model Number: L103868
• Device Catalogue Number: L103868
• Device Lot Number: 10489410
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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 Sex: Unknown