MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, SYSTEM MONITOR; Ventricular (assist) bypass

Model Number	1286
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system monitor ii had no touch response.The system monitor was scrapped.
Additional Manufacturer Narrative
A1-a6: no patient involved.Manufacturer's investigation conclusion: the reported event of the system monitor not responding to touch was confirmed via evaluation of the returned system monitor.The heartmate system monitor, serial number: (b)(6), was inspected at the service depot on (b)(6) 2024.The unit was connected to ac power but would not power on.Due to the device being discontinued, the unit was not supported for repair and was forwarded to product performance engineering (ppe) for further evaluation.Upon arrival at the ppe department, the system monitor not powering on was reproduced.The main printed circuit board (pcb) was replaced, and the system monitor was able to power on and function as intended.Further analysis of the main pcb revealed a compromised component in the power supply circuitry that prevented power from being supplied to the rest of the circuit, resulting in the system monitor being unable to power on.The account was unable to provide any additional information as they did not have access to specific case details; therefore, no additional information was able to be obtained.A root cause for the system monitor being unresponsive was determined to be due to a compromised component on the system monitor main printed circuit board (pcb); however, root cause of the component not functioning properly could not be conclusively determined through this analysis.The device history records were reviewed and the records reveals that the heartmate system monitor, serial number vsm-4723, was manufactured in accordance with manufacturing and qa specifications.The system monitor was shipped to the customer on 21oct2014.The heartmate power module instructions for use was available for use at the time of the event.Section 2 entitled ¿setting up the power module (pm) prior to use¿ covers set up and use of the system monitor with the power module.The heartmate 3 patient handbook was available for use at the time of the event and cautions the 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: THORATEC® HEARTMATE®, SYSTEM MONITOR
• 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: 20517076
• Report Number: 2916596-2024-07073
• Device Sequence Number: 12953778
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 10/23/2024

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: 1286
• Device Catalogue Number: 1286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• 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: 10/17/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown