MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE TOUCH¿; VENTRICULAR (ASSIST) BYPASS

Model Number	HMT1100
Medical Device Problem Codes	Failure to Charge (1085); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h6 - medical device problem code: corrected manufacturer's investigation conclusion: the reported event of the heartmate touch screen remaining black despite being connected to the charger was not confirmed.Additional information provided stated that the issue was resolved by readjusting and manipulating the power cord and the heartmate touch would not be returned for evaluation.The root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate 3 instructions for use (ifu) chapter 4 ¿heartmate touch communication system¿ and the heartmate touch communication system quick start guide explain the operation of the heartmate touch system, including how to set up the heartmate touch communication system for use and how to turn on the tablet.The user is instructed to fully charge the heartmate touch tablet or plug in the power cable during set-up.Heartmate 3 instructions for use (ifu) chapter "equipment storage and care" describe how to care for, store, and clean all equipment, including the heartmate touch tablet.Heartmate 3 instructions for use (ifu) chapter 1 "introduction" informs the user to contact abbott for assistance if there are any questions after reading the manual.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
B5: additional information no further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.
Event or Problem Description
It was further reported that heartmate touch was able to be charged and functioning as intended.
Event or Problem Description
It was reported that the heartmate touch screen remained black no matter how long it had been on the charger.The issue was unable to be troubleshooted.
Additional Manufacturer Narrative
A1-a6: no patient involvement.No further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.
Event or Problem Description
The issue resolved after readjusting/ manipulating the power cord.The cause of the black screen was unable to be determined.
Additional Manufacturer Narrative
No further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.

• Brand Name: HEARTMATE TOUCH¿
• 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: 19766556
• Report Number: 2916596-2024-04511
• Device Sequence Number: 8725307
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: (01)05415067032058(11)230609
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/13/2024

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: HMT1100
• Device Catalogue Number: HMT1100
• Device Lot Number: 9064401
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 08/27/2024; 09/12/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/09/2024; 09/11/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2023
• 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 Sex: Unknown