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

Model Number	1440
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a charging issue with slot 3 of the universal battery charger (ubc) was confirmed.During the evaluation of the returned ubc, serial (b)(6), the unit was plugged into ac power and showed a red light error code on channel 3.There was light smoke and a slight odor that came from the unit.The unit was powered off and the unit was internally inspected.Thick reddish liquid was noted to cover multiple components of the main pcba resulting in multiple electrically compromised components on channel 3.No further testing was performed.The customer declined to have the ubc repaired, and the unit was disposed of.A root cause for the reported event was due to fluid ingress on the main pcba resulting in damage.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.The universal battery charger (ubc) instructions for use (ifu) 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 universal battery charger (ubc) received a battery charger fault alarm to pocket 3 error code with telephone icon + s0003.The patient was unable to charge the battery and was provided a new ubc.The program requested the device be evaluated and repaired within warranty.

• 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: 22738807
• Report Number: 2916596-2025-05120
• Device Sequence Number: 7198351
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: (01)00813024010678(11)240618
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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
• Device Lot Number: L00000443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• 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: 07/28/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 64 KG