MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE SYSTEM MONITOR; VENTRICULAR (ASSIST) BYPASS

Model Number	1286C
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was reported that the patient's system monitor displayed a "replace backup battery" alarm.The backup battery was exchanged but the alarm still displayed on the system monitor.The battery was then exchanged a second time, but the alarm still did not resolve.The system controller was then exchanged.
Additional Manufacturer Narrative
Section b5 describe event or problem: corrected.Section d4 primary unique device identification (udi) number: corrected.Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.Manufacturer's investigation conclusion: the reported event of the system monitor displaying incorrect information was not confirmed.The system monitor displayed a replace backup battery alarm accurately, as the connected system controller backup battery did not pass its load test.The system monitor was not returned for analysis.The device history records have not been reviewed due to the lot and serial numbers not being provided.Heartmate system monitor instructions for use (ifu) (rev.B) informs the user to refer any servicing of heartmate lvas equipment to trained service personnel only.Heartmate 3 instructions for use (rev.C) section 4 ¿system monitor¿ and heartmate 3i patient handbook (rev.D) section 6 ¿caring for the equipment¿ explain how to properly handle the monitor to prevent damage.The heartmate 3 patient handbook (rev.D) and the heartmate 3 patient handbook (rev.C) caution the 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.
Event or Problem Description
Additional information reported that the exchange of the system controller resolved the alarms.

• Brand Name: 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: 19600217
• Report Number: 2916596-2024-04117
• Device Sequence Number: 8084969
• Product Code: DSQ
• UDI-Device Identifier: 00813024010852
• UDI-Public: (01)00813024010852
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: Lay User/Patient
• Device Model Number: 1286C
• Device Catalogue Number: 1286C
• Was Device Available for Evaluation?: No
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 84 KG