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

Model Number	1440
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient traveled out of the united states (us) to lisbon, portugal and called the ventricular assist device (vad) team to request a new universal battery charger (ubc) as theirs "blew up" while connected to power.No damage to the room or anyone was noted and no further issues were reported.The extent of the damage to the ubc was reported as it was not working, and no damage to the 14v batteries was noted.As of (b)(6) 2023, the patient was still in portugal and if a converter was used or if european union (eu) patient cable was used was to be requested upon their return to the us.The patient was instructed to bring the back the damaged ubc and was also to be contacted to provide pictures of the damage.The patient was provided with a new ubc.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
A converter was used but a european union (eu) power cord was not.On the new ubc, the patient used the eu power cord while on their trip in portugal and a us power cord after their return home.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the universal battery charger (ubc) becoming damaged while the patient was traveling was confirmed.The ubc (serial number: (b)(6)) was returned to the service depot and was evaluated and on 21feb2024.During investigation of the ubc, damaged components on the main printed circuit board (pcb) were found.No further testing was performed and the ubc was forwarded to product performance engineering (ppe) for further analysis.During further investigation with ppe, the ubc was powered on and booted up as intended.A 14v li-ion battery was inserted into each slot.Each battery reached full charge without any issues or alarms becoming active on the ubc.The ubc was allowed the run with the charged batteries, in each slot, for an extended duration.No issues became active.Upon opening the ubc damage to a capacitor (c72) was observed.This damage did not affect the operation of the ubc; however, may have been related to the reported event.No further testing was performed.The root cause for the reported event was unable to conclusively determined through this analysis.The device history records were reviewed for the universal battery charger (serial number: (b)(6)) and the universal battery charger passed all manufacturing and qa specifications.Customer order (b)(4) was shipped on 11jan2018.Heartmate 3 instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate 3 patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.Heartmate ubc instructions for use section 5 entitled ¿responding to advisory messages¿ addresses how to properly interpret and troubleshoot all system alarms and the actions to take if the alarms cannot be resolved.Heartmate ubc instructions for use section 2.1 entitled ¿plugging in and turning on the charger¿ states that if traveling internationally, you will need a thoratec power cord set that is compatible with the local voltage and that meets applicable national plug, rated voltage, rated current, and safety agency marks and specification.Heartmate universal battery charger instructions for use section 8 ¿ ¿inspection, cleaning, and maintenance¿ explain how to properly care for the equipment.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.No further information was provided.The manufacturer is closing the file on this event.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18274035
• Report Number: 2916596-2023-08196
• Device Sequence Number: 5723471
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: 813024010678
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2017
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 92 KG