MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number	P/N 397002-001
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
C2 driver touch screen was not working appropriately.When screen is pressed it did not always acknowledge it.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed companion 2 driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of internal and external components found no abnormalities.Driver passed all areas of functional testing for acceptance at incoming inspection, however, it was confirmed that the touchscreen would not consistently respond properly unless excess pressure was used.Additional testing included installing a known functional lcd screen.The touchscreen worked properly as intended and the driver functioned normally with the replacement part.Failure investigation for this complaint confirmed the reported issue during functional testing.The customer complaint was replicated; the root cause of the reported issues with the touchscreen not working consistently or without undue effort was determined to be a nonconforming lcd touchscreen.Failure investigation identified no test failures or damage that could have contributed to the event.The device was not in patient use at time of the complaint.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.
Event or Problem Description
C2 driver touch screen was not working appropriately.When screen is pressed it did not always acknowledge it.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Common Device Name: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer Contact: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; 3104239543
• MDR Report Key: 20859708
• Report Number: 3003761017-2024-00127
• Device Sequence Number: 17109750
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2025

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: Health Professional
• Device Catalogue Number: P/N 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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