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	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system monitor at the hospital was checked because it was scheduled for use, but the touch operation was not recognized.There was no patient involvement.There were no alarms associated with the event.
Additional Manufacturer Narrative
There was no patient involved in this event.The pma# provided is associated with most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the heartmate system monitor (serial number: (b)(6) not responding to touch input could not be confirmed through this analysis.Provided information indicated that the system monitor was rebooted before use.Although the system monitor was not returned for evaluation, a corrective and preventative action (capa) was opened to further investigate issues related to the system monitor atypical screen behavior.The device history records were reviewed, and the records revealed the system monitor (serial number: (b)(6) was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 patient handbook section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible) and the actions to take if the alarms cannot be resolved.The heartmate 3 ifu section 4, entitled ¿system monitor¿, instructs the user on how to setup and use the system monitor with the heartmate power module.Heartmate 3 patient handbook section 6, entitled "caring for the equipment", describes how to care for and clean all equipment, including the system monitor.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad.Heartmate 3 patient handbook 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.The device is included in the system monitor atypical screen behavior advisory issued by abbott on 08 may 2024.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
The system monitor was rebooted before use.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• 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: 19958252
• Report Number: 2916596-2024-04960
• Device Sequence Number: 7080056
• Product Code: DSQ
• UDI-Device Identifier: 00813024010852
• UDI-Public: (01)00813024010852(11)181026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 10/11/2024
• Initial Report FDA Received Date: 08/11/2024
• Supplement Report FDA Received Date: 09/23/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2018
• 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