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

Model Number	1286A-US
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system monitor settings tab button stopped working when the surgeon tried to turn up the speed and come off bypass during a heartmate ii implant procedure.The system monitor screen was cleaned, the system monitor was turned off and back on, and unplugged and plugged back in.The clinical, admin, and history tabs worked fine, but the settings tab did not function.The system monitor appeared to need touchscreen calibration.Another system monitor was brought into the operating room to be used.The original system monitor was brought to the hospital's biomed department.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the system monitor confirmed the reported event of the unit not functioning properly.The system monitor touchscreen required re-calibration which resolved the event.The system monitor was tested and returned to the customer's site.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.Setup and use of the system monitor with the heartmate power module are documented in the heartmate power module instructions for use (ifu) (rev.B, section titled ¿setting up the system monitor for use with the power module¿) and the heartmate ii ifu (rev.C) under section 4 ¿system monitor¿.The heartmate ii ifu recommends that users contact abbott if the system monitor¿s screen is malfunctioning.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: 19488184
• Report Number: 2916596-2024-03672
• Device Sequence Number: 7089173
• Product Code: DSQ
• UDI-Device Identifier: 00813024010852
• UDI-Public: (01)00813024010852(11)051201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• 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): 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: 44038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• 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: 12/01/2005
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic
• Patient Race: White