MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION EXTERNAL BATTERY PACK

Catalog Number	293001-001
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer, a syncardia certified hospital, reported that when the companion external battery was installed in the companion 2 driver, there was an error symbol over the battery icon on main driver display.The customer also reported the companion external battery gauge lights did not work.
Additional Manufacturer Narrative
The companion external battery will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
Additional Manufacturer Narrative
The customer confirmed that they have lost the companion external battery pack.Syncardia is closing this file.(b)(4) follow-up report 1.
Additional Manufacturer Narrative
Companion external battery pack was located by customer and returned to manufacturer for investigation.Device history record (dhr) review confirmed that companion external battery s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and data file review found no alarms or failures.Visual inspection of external components found no abnormalities.Battery passed all areas of functional testing for acceptance at incoming inspection.Additional testing included installation into an onsite test companion 2 driver.Upon installation, battery gas gauge led started flashing indicating battery was charging.The battery was allowed to charge to capacity and driver was removed from ac power to run on the battery exclusively.Driver ran successfully on battery for 25 minutes indicating battery was functioning as intended.Complaint could not be replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint was not replicated; the root cause of the reported inability of the driver to function with this specific battery, was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.The battery functioned as intended and no evidence of a malfunction was found.Companion 2 driver in use at the time was not returned for investigation, however, it was reported that the driver functioned normally with a different battery.Battery 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.
Event or Problem Description
The customer, a syncardia certified hospital, reported that when the companion external battery was installed in the companion 2 driver, there was an error symbol over the battery icon on main driver display.The customer also reported the companion external battery gauge lights did not work.

• Brand Name: SYNCARDIA COMPANION EXTERNAL BATTERY PACK
• Common Device Name: BATTERY
• 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: 14847090
• Report Number: 3003761017-2022-00059
• Device Sequence Number: 4744215
• Product Code: LOZ
• UDI-Device Identifier: 00858000003077
• UDI-Public: (01)00858000003077
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 06/26/2024

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: Health Professional
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 06/02/2022; 06/02/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 09/07/2022; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2016
• 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