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

Catalog Number	P/N 397002-001
Medical Device Problem Codes	Battery Problem (2885); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per distributor, after system checkout, device displayed message, single compressor malfunction.Also, internal battery could not be charged.Device not in patient use at time of complaint.
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 one single compressor malfunction alarm recorded in the driver's data file with a beat rate set to zero at the time of the alarm.Visual inspection of internal and external components found no abnormalities.Driver passed all functional testing for acceptance at incoming inspection.Additional testing included a test of the emergency battery which functioned as intended.The single compressor malfunction could not be replicated.Failure investigation for this complaint confirmed the reported issue from the patient data file review.The customer complaint could not be replicated during testing; the root cause of the reported emergency battery not charging and the single compressor malfunction was unable to be determined.Failure investigation identified no other test failures or damage that could have contributed to the reported complaint.Single compressor malfunctions could be linked to multiple scenarios and are currently being investigated.Alarms correspond with mitigation efforts to ensure safety and occurred as intended.No evidence of a device malfunction was found.Device was not supporting a patient 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.
Event or Problem Description
Per distributor, after system checkout, device displayed message, single compressor malfunction.Also, internal battery could not be charged.Device not in patient use at time of complaint.

• 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: 20050768
• Report Number: 3003761017-2024-00100
• Device Sequence Number: 15447975
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (Y/N): N
• 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: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/28/2025
• 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