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

Catalog Number	293001-001
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The companion external battery will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
Event or Problem Description
The companion external battery was not supporting a patient at the time of the event.The customer, a syncardia certified hospital, reported that the companion external battery only charged to 60% of its capacity.
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
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 patient data file review found no alarms or failures.Visual inspection found no abnormalities.Companion external battery passed all areas of functional testing for acceptance at incoming inspection.Complaint could not be replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint was not replicated during testing; the root cause of the reported inability to charge battery beyond 60% capacity was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the reported complaint.No evidence of a device malfunction was found.Device was not in patient use at time of the 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 companion external battery was not supporting a patient at the time of the event.The customer, a syncardia certified hospital, reported that the companion external battery only charged to 60% of its capacity.

• 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: 14877482
• Report Number: 3003761017-2022-00061
• Device Sequence Number: 20291505
• 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): 06/10/2024

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: 06/09/2022
• Supplement Date Received by Manufacturer: 06/09/2022; 09/27/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/07/2022; 06/10/2024
• 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