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

Catalog Number	P/N 397002-001
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per manufacturer quality technician, companion 2 driver was connected for for five days to power to let emergency battery to charge for routine service.Driver failed step op 070 on service shop order due to observed emergency battery error.Incoming inspection could not continue.
Event or Problem Description
Per manufacturer quality technician, companion 2 driver was connected for for five days to power to let emergency battery to charge for routine service.Driver failed step op 070 on service shop order due to observed emergency battery error.Incoming inspection could not continue.
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 battery error alarm.Visual inspection of internal components found no abnormalities.Visual inspection of external components found no abnormalities initially, however, during additional testing, capacitor damage discovered on power management board.Companion 2 driver failed functional testing for acceptance at incoming inspection due to emergency battery error.Additional testing included evaluating the battery using gas gauge evaluation software where no permanent faults were found, however, it was observed that the cells were imbalanced with cell 1 displaying cell under voltage flag.Battery was replaced with new unit from stock and left to charge over the weekend.Upon startup, emergency battery error was still displayed.Further investigation revealed a blown capacitor on power management board.Replacement board from stock was installed along with original emergency battery.Driver still booted up to emergency battery error, however this was due to the emergency battery having a severe cell imbalance.As a result the emergency battery was replaced.The unit was able to pass all subsequent testing with the replacement board and battery installed.Customer complaint was replicated during testing.Failure investigation for this complaint confirmed the reported issue from alarm and patient data file review, in addition to observation of damaged capacitor.The customer complaint was replicated during functional testing; the root cause of the reported battery failure was determined to be a blown capacitor on the pcb assembly power management board.Failure investigation identified no other test failures or damage that could have contributed to the event.Device was not in patient use at time of 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.

• 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: 22709982
• Report Number: 3003761017-2025-00125
• Device Sequence Number: 13079855
• 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: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: Other
• Device Catalogue Number: P/N 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 02/26/2026
• 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 Sex: Unknown