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

Model Number	1340
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power module had a damaged casing and would be returned for repair.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of power module case damage was confirmed via evaluation of heartmate power module (serial number (b)(6)) at the service depot.Visual inspection revealed that the top and bottom housing was damaged, a rubber foot was deteriorated, there was tearing around the handle overlay silent button, and the battery clip and battery bracket were missing.The damaged parts were replaced and the repaired unit underwent functional checkout.The power module passed all tests and was returned to the customer site.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The root cause for the reported event was unable to be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance (qa) specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The heartmate 3 ifu (rev.D), section f - "safety checklists", provides checklists to perform routine maintenance of the equipment, including the power module and power module backup battery.The heartmate 3 ifu, section 8 - ¿equipment storage and care¿ and heartmate 3 patient handbook, section 6 - ¿caring for the equipment¿, explain how to properly care for all the equipment to prevent damage.The heartmate power module ifu, section 11.0 - ¿routine maintenance¿, instructs users to bring their power module to an authorized service technician at least once per year for a thorough inspection and cleaning.Routine maintenance also includes the unit¿s internal backup battery being replaced.The patient handbook 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.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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24083374
• Report Number: 2916596-2026-00356
• Device Sequence Number: 18563036
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: (01)00813024010654(11)150706
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 01/15/2026

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: Health Professional
• Device Model Number: 1340
• Device Catalogue Number: 1340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• 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: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2015
• 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