MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE UNIVERSAL BATTERY CHARGER; VENTRICULAR (ASSIST) BYPASS

Model Number	1440
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were black burn marks where the 14v battery was connected in the hospital universal battery charger (ubc).Related manufacturer's report: 2916596-2023-05449.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is completed.Section a4: patient weight has been requested but not yet provided.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the universal battery charger (ubc) was evaluated following the reported event of a burn mark on the 14v battery.There was no photos or log files submitted for review.The ubc, serial (b)(6), was not returned for analysis.There were no reported issues with the unit.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.Battery usage and charging faults are addressed in the heartmate 3 lvas patient handbook (rev.D), heartmate 14 volt li-ion battery instructions for use (ifu) (rev e) and the heartmate universal battery charger (ubc) ifu (rev.B).Heartmate 3 instructions for use (rev.C) section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook (rev.D) section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot ubc alarms.Heartmate 3 instructions for use (rev.C) section 3-¿powering the system¿ and heartmate 3 patient handbook (rev.D) section 3-¿powering the system¿ explain how to clean and maintain proper function of the batteries.The ifu states under the weekly safety checklist to clean the metal battery terminals and contacts inside the battery clips and to check for damage.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
Additional information: the cause of the burn marks was not identified.The ubc remained in service.

• Brand Name: HEARTMATE UNIVERSAL BATTERY CHARGER
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17366844
• Report Number: 2916596-2023-05186
• Device Sequence Number: 6647687
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: 813024010678
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2017
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 78 KG