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	09/09/2020
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 the system monitor screen not responding to touch commands, was confirmed when the unit was checked by technical service.The resistive touchscreen glass was replaced.The system monitor was tested and returned to the customer.Per device build and service records, the touchscreen glass was installed in the unit when it was built ((b)(6) 2005).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 system monitor (part number 101214) was built in (b)(6) 2005.The packaged system monitor (part number 1286) was placed into inventory on (b)(6) 2005.The unit was placed int the rental/loaner pool on (b)(6) 2006.The unit was shipped to the customer on 03mar2006 ¿ long-term rental.The unit was last serviced on (b)(6) 2017 ¿ software version 7.32 upgrade.Per service record reviews, the touchscreen glass was installed when the unit was built (in (b)(6) 2005).Setup and use of the system monitor with the heartmate power module are documented in the heartmate power module instructions for use (ifu) (setting up the system monitor for use with the power module), the heartmate ii left ventricular assist system (lvas) ifu (system monitor) and the heartmate 3 lvas ifu (system monitor).No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the settings on the system monitor would not work.The system monitor needed to be recalibrated.This issue occurred during a class, the system monitor was not hooked up to a patient.

• 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: 19491427
• Report Number: 2916596-2024-03734
• Device Sequence Number: 7106776
• Product Code: DSQ
• UDI-Device Identifier: 00813024010852
• UDI-Public: (01)00813024010852(11)050404
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 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: 43408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• 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: 04/04/2005
• 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 Sex: Unknown