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	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per hospital staff, touch screen on companion 2 driver (b)(6) will not change beat rate while in icu mode.Screen calibrated multiple times and beat rate is not able to be adjusted while in icu mode.Driver was swapped out for another driver without any adverse impact to patient.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that companion 2 driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found no new alarms or relevant errors recorded.Visual inspection of external components found no abnormalities.Visual inspection of internal components found a partially crushed cable related to the driver display assembly.Companion 2 driver failed functional testing for acceptance at incoming inspection due to a nonconforming 9v battery.Additional testing included adjusting parameters included in the complaint while in icu mode.There were no difficulties with screen calibration in icu mode and the customer complaint was unable to be replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint was not replicated during testing; the root cause of the reported issue adjusting the beat rate while in icu mode was unable to be determined.Failure investigation identified no other test failures or damage that could have contributed to the complaint.The damaged cable on the driver display assembly relates to the backlight of the display, not the touch control, and would not have had an impact on the reported issue.The nonconforming 9v was unrelated to the reported complaint and would not affect the functionality of the driver display.No evidence of a device malfunction was found and the driver performed as designed.The patient was switched to a backup driver without any reported adverse impact.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
Per hospital staff, touch screen on companion 2 driver s/n (b)(6) will not change beat rate while in icu mode.Screen calibrated multiple times and beat rate is not able to be adjusted while in icu mode.Driver was swapped out for another driver without any adverse impact to patient.

• 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 ; 5205451234
• MDR Report Key: 23079334
• Report Number: 3003761017-2025-00143
• Device Sequence Number: 13260993
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/21/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 04/21/2026
• 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 Age: 22 YR
• Patient Sex: Male