MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, SYSTEM MONITOR; VENTRICULAR (ASSIST) BYPASS

Model Number	1286
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the system monitor showed no data received on screen when connected to the system controller.Troubleshooting would be performed with the patient cable.
Additional Manufacturer Narrative
Section d5: operator of device corrected section g3: pma # corrected.There was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.Section h6: health effect - impact code and medical device problem code corrected manufacturer¿s investigation conclusion: the reported event of the system monitor displaying ¿no data received" was not confirmed.The heartmate system monitor s/n: (b)(6) was not returned for analysis.Per the provided information, when the clinic tried to use the system monitor with a system controller the reported message was displayed.It was stated the patient cable would be inspected at the clinic to identify if it was the cause of the problem, no response was given when asked if the patient cable was the origin of the communication issue.No photos were submitted for review.Multiple attempts were made to obtain additional information, but the customer only stated that there was no patient involvement and did not provide any more data related to the event.The root cause of the reported event could not be conclusively determined through this analysis.The device history record for the system monitor serial number (b)(6) were reviewed.No deviations from manufacturing or qa specifications were shown from the system monitor.The system monitor was shipped to the customer on (b)(6) 2013.Heartmate system monitor instructions for use (rev.E) informs the user to refer any servicing of heartmate lvas equipment to trained service personnel only.Heartmate 3 instructions for use (rev.C) section 4 ¿ ¿system monitor¿ addresses how to properly use the system monitor, and the actions to take if the system monitor is not functioning as intended.This section also states how to view the system controller event history on the system monitor.The heartmate 3 patient handbook (rev.D) and the heartmate 3 instructions for use (rev.C) caution the user 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: 19872714
• Report Number: 2916596-2024-04829
• Device Sequence Number: 7114296
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142(11)130401
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: Health Professional
• Device Model Number: 1286
• Device Catalogue Number: 1286
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2013
• 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