MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER EXTERNAL BATTERY; EXTERNAL POWER SUPPLY

Catalog Number	293001-001
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer, a syncardia certified hospital, reported that the companion 2 driver was plugged in running on wall power, and then alarmed ¿external battery error.¿ the customer changed the battery and there were no further alarms.
Additional Manufacturer Narrative
The companion 2 driver external battery will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that companion 2 driver external battery s/n 40751 was serviced and passed all functional testing prior to being released to finished goods.Battery data file review found no failures.Visual inspection of external components found no abnormalities.Battery passed all functional testing for acceptance at incoming inspection.Additional testing included operational testing within an known functional c2 driver.Battery was recognized and indicated it was charging.After charging to 100%, battery was allowed to discharge freely without the ac power connected to the driver.The driver operated regularly for 25 minutes without issue.Battery was able to charge/discharge normally without issue.Complaint was not replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint was not replicated; root cause of the reported "external battery error" message was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.No evidence of a device malfunction was found.External battery was replaced in patient's 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
The customer, a syncardia certified hospital, reported that the companion 2 driver was plugged in running on wall power, and then alarmed "external battery error." the customer changed the battery and there were no further alarms.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER EXTERNAL BATTERY
• Common Device Name: EXTERNAL POWER SUPPLY
• 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: maia kirk ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16414849
• Report Number: 3003761017-2023-00014
• Device Sequence Number: 3504210
• Product Code: LOZ
• UDI-Device Identifier: 00858000003077
• UDI-Public: (01)00858000003077
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: Lay User/Patient
• Device Catalogue Number: 293001-001
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2017
• 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: 37 YR
• Patient Sex: Male