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

Catalog Number 397002-001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2023

Event Type  malfunction  

Event Description

C2 (b)(6) returned for service and failed testing at incoming inspection.Driver does not recognize external batteries charge and the external ac/dc main power source cable.In addition, the emergency battery error pop up after the boot up process.

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 fault alarm consistent with an emergency battery error.Visual inspection of external components found no abnormalities.Visual inspection of internal components found no abnormalities.Companion 2 driver failed functional testing at incoming inspection due to emergency battery error and driver not recognizing external batteries charge and external ac/dc main power source cable.Additional testing was performed resulting in the original power management board's capacitor burning up while powering on the driver.A replacement board was utilized to complete testing, resulting in driver passing all areas of testing and inspection.Failure investigation for this complaint confirmed the reported issue.The customer complaint was not specifically replicated during testing, however, a device malfunction did occur; the root cause of the emergency battery error and the inability of the driver to recognize external battery charge and ac/dc main power cable was due to a faulty power management board.Failure investigation identified no other test failures or damage that could have contributed to the complaint.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
• Type of Device: 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: aaron meier ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 18106846
• MDR Text Key: 328275958
• Report Number: 3003761017-2023-00161
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2023

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
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1