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

Model Number	1286
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a rental system monitor located in the sites storage area was not illuminating despite power being delivered to the system (green light illuminated and 3 beeps were heard).The monitor was turned on and off, a new power cable was used, and a new power module was used but the problem persisted.A new monitor was to be sent to replace the current rental unit.The site communicated that the cause of the issue was not determined.The product was sent back for evaluation.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the system monitor not illuminating as intended was not confirmed.The returned system monitor (serial number (b)(6)) was functionally tested and performed as intended throughout all testing.No issues regarding the monitor¿s illumination were observed.The root cause of the reported event was unable to be determined through this analysis.A corrective and preventative action (capa) was opened to further investigate issues related to the system monitor atypical screen behavior.Review of the device history record for the system monitor, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 instructions for use (ifu) (rev.C) under section 4, entitled ¿system monitor¿, provides an overview of the system monitor and explains how to set up and use it.This section contains troubleshooting steps for the system monitor and instructs the user to contact abbott for assistance if the system monitor still does not work.Heartmate 3 instructions for use (ifu) (rev.C) section f, entitled ¿safety checklists¿, provides checklists to assist the user in performing routine maintenance of the heartmate 3 lvad.Heartmate 3 patient handbook (rev.D) 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: 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: 20138446
• Report Number: 2916596-2024-05946
• Device Sequence Number: 15303260
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• 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: 09/03/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2021
• 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