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

Model Number	1286A-US
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section g4: there was no patient involved in this event.The pma# provided is associated with most recent approval.Manufacturer's investigation conclusion: the reported event of a dim display on the system monitor was unable to be confirmed.The returned system monitor (serial number: (b)(6) was tested and evaluated at the service depot on (b)(6) 2022.The system monitor was connected to a test loop and run for several days with no issues observed during the investigation period.The monitor was functionally tested and passed all tests.A monitor backlight test was performed several times and the monitor passed the test each time.The monitor is ready for use and will be returned to the customer.A root cause for the reported event was unable to conclusively determined through this investigation.A corrective and preventative action (capa) was opened to further investigate issues related to the system monitor atypical screen behavior.The device is included in the system monitor atypical screen behavior advisory issued by abbott on 08 may 2024.The device history records were reviewed and the records revealed the heartmate system monitor (serial number: (b)(6) was manufactured in accordance with manufacturing and quality assurance specifications.Customer order was shipped on (b)(6) 2011.Setup and use of the system monitor with the heartmate power module are documented in the heartmate power module instructions for use (ifu) section titled ¿setting up the system monitor for use with the power module¿).Per the power module ifu (section 9.0 ¿routine maintenance¿), users are instructed to regularly inspect the equipment for damaged pins and connectors, including the system monitor, and to obtain replacements if necessary.Per the power module ifu, if the system monitor does not function properly, contact the company's technical service department.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that system monitor screen was dim after it was repaired by the manufacturer for a ram error.The system monitor failed the hospital's incoming inspection.

• 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: 19489670
• Report Number: 2916596-2024-03585
• Device Sequence Number: 20624123
• Product Code: DSQ
• UDI-Device Identifier: 00813024010852
• UDI-Public: (01)00813024010852(11)110301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: 1286A-US
• Device Catalogue Number: 1286A-US
• Device Lot Number: 101920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• 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: 05/08/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2011
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q224-HF-1
• Patient Sequence Number: 1
• Patient Sex: Unknown