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	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Related regulatory reference report mfr # 2916596-2023-07208; 2916596-2023-07209; 2916596-2023-07210; 2916596-2023-07211.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the metal contacts of the batteries were burned.The battery charger charging the batteries also had burn marks on the internal metal contacts.The four batteries and battery charger would be replaced.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of damaged contacts on the universal battery charger (ubc) was not confirmed.During the evaluation of the returned ubc, serial (b)(6) , the unit was noted to be in good condition; no anomalies were found.Visual inspection showed no signs of damage on the metal contacts or anywhere else on the unit.The system booted up and functioned as intended.The unit was able to charge batteries on all slots without issue.All tests were performed per procedure and passed all steps.The customer was sent a replacement unit and this unit was removed from service and forwarded to product performance engineering (ppe).Visual inspection of the returned ubc revealed no anomalies.The charger contacts were all unremarkable and when the unit was plugged into power, it booted up as intended.All slots were able to charge batteries without issue.A root cause for the reported event cannot be conclusively determined through this investigation.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) (rev.B) 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.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of damaged contacts on the universal battery charger (ubc) was not confirmed.During the evaluation of the returned ubc, serial (b)(6), the unit was noted to be in good condition; no anomalies were found.Visual inspection showed no signs of damage on the metal contacts or anywhere else on the unit.The system booted up and functioned as intended.The unit was able to charge batteries on all slots without issue.All tests were performed per procedure and passed all steps.The customer was sent a replacement unit and this unit was removed from service.A root cause for the reported event cannot be conclusively determined through this investigation.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) (rev.B) 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 additionally reported that the patient was not burned.

• 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: 17860842
• Report Number: 2916596-2023-07207
• Device Sequence Number: 20257093
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: 00813024010678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2024

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: 1440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 01/17/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 01/05/2024; 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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: 23 YR
• Patient Sex: Male
• Patient Weight: 48 KG