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

Catalog Number	P/N 397002-001
Medical Device Problem Codes	Output Problem (3005); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While supporting the patient there were periodic "left pressure incorrect" notifications on the alarm notification area on the c2 driver and hospital cart.The patient was stable and the waveforms continued to show full eject and partial fill status.Patient's cardiac output was not affected and was completely stable in his physiologic parameters.Patient was switched to a freedom driver without any reported adverse impact.
Event or Problem Description
While supporting the patient there were periodic "left pressure incorrect" notifications on the alarm notification area on the c2 driver and hospital cart.The patient was stable and the waveforms continued to show full eject and partial fill status.Patient's cardiac output was not affected and was completely stable in his physiologic parameters.Patient was switched to a freedom driver without any reported adverse impact.
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 multiple left pressure incorrect alarms.Visual inspection of internal and external components found no abnormalities.Driver failed functional testing due to the lcd screen showing a white screen, although, the hospital cart showed the driver's proper display.The lcd cable was loose and was re-inserted correctly which corrected the issue.Although this issue is unrelated to the customer complaint, resolving the issue allowed for repeat functional testing.Driver passed all functional testing and a 48-hour observation was performed with driver set to same patient parameters at time of complaint.Driver functioned as intended without issue or alarm.Customer complaint was not replicated.Failure investigation for this complaint confirmed the reported issue from alarm data file review.The customer complaint was not replicated; the root cause of the reported left pressure incorrect alarms was unable to be determined.Failure investigation identified no other test failures or damage that could have contributed to the reported complaint.The lcd screen issues that were resolved during testing were unrelated to the customer complaint.No evidence of a device malfunction was found.No adverse impact to patient reported.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: 21231602
• Report Number: 3003761017-2025-00084
• Device Sequence Number: 18293461
• 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): 04/22/2025

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: 01/17/2025
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 04/22/2025
• 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