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

Model Number	1440
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of burn damage on the universal battery charger (ubc) was not confirmed.There were no photos submitted for review.The ubc, serial(b)(6).Was not returned for analysis.The provided information stated that the unit was exchanged due to burn damage from the patient's house fire.The replaced equipment is not available for analysis since the hospital disposed of them per local regulations.Additional information provided stated that there were no photos available of the damage.A root cause for the reported event was not conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.The patient handbook cautions 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.The universal battery charger (ubc) instructions for use (ifu) explains under the responding to advisory messages how to troubleshoot any errors or alarms.It states under the precautions section: "the metal contacts inside the ubc pockets should be kept clean and dry.Do not expose contacts to water, moisture, dirt, etc.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient's universal battery charger (ubc) was using a non-manufacturer power cord and had burn damage from a small house fire.The ubc was exchanged and discarded.

• Brand Name: HEARTMATE®
• 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: 21875718
• Report Number: 2916596-2025-02291
• Device Sequence Number: 7719249
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: (01)00813024010678(11)120301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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: 1440
• Device Catalogue Number: 1440
• 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: 03/27/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2012
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 70 KG