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

Model Number 1286A-US

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

There is no patient involved in this event.The pma# provided is associated with the most recent approval.Manufacturer's investigation conclusion: there were incidental findings of bent pins on memory card slot.The reported event of the system monitor turning on was confirmed.Initial inspection of the returned system monitor, serial (b)(4), revealed a severed internal power cable.The internal power cable was replaced resolving the issue.The system monitor underwent functional testing and passed all steps without any issue.A root cause of the reported event was determined to be damaged internal power cable; however, the root cause of the damaged internal power cable was not determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.(b)(4) was shipped to the customer on 01-may-2012 in customer order.Heartmate system monitor instructions for use (ifu) informs the user to refer any servicing of heartmate lvas equipment to trained service personnel only.Heartmate ii instructions for use section 4-¿system monitor¿ and heartmate ii patient handbook section 6-¿caring for the equipment¿ explain how to properly handle the monitor to prevent damage.Heartmate iii instructions for use section 4-¿system monitor¿ and heartmate iii patient handbook section 6-¿caring for the equipment¿ explain how to properly handle the monitor to prevent damage.The heartmate ii patient handbook and the heartmate 3 patient handbook 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 Description

It was reported that the patient's system monitor would not power on and the connector on the back of the monitor was damaged.

• Brand Name: HEARTMATE SYSTEM MONITOR
• Type of Device: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14242637
• MDR Text Key: 290535162
• Report Number: 2916596-2022-10705
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010852
• UDI-Public: 00813024010852
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1286A-US
• Device Catalogue Number: 1286A-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1