MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY

Catalog Number	295025-001
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The freedom onboard battery will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
Event or Problem Description
The freedom onboard battery was not supporting a patient at the time of the event.The customer, a (b)(6) hospital, report that the freedom onboard battery did not hold a charge.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that freedom onboard battery s/n (b)(6) was evaluated and passed all initial testing prior to being released to finished goods.Battery data review found no failures.Data could only be retrieved by connecting battery to a power supply, indicating negative communication,however.Visual inspection found no abnormalities.Battery failed functional testing; negative communication observed and gas gauge leds would not illuminate when button pressed.Additional testing was performed to test battery charge and ability to power driver.Battery failed to charge and was unable to power driver, confirming customer complaint.Failure investigation for this complaint confirmed the reported issue, the battery does not hold a charge and is unable to power driver.The complaint was replicated during testing; the root cause was determined to be a device malfunction as the battery became permanently disabled.Freedom onboard batteries incorporate a safety feature to disable functionality when the battery is compromised.Patient was not using the battery at the time so there was no reported adverse impact or risk to the patient.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.
Event or Problem Description
The freedom onboard battery was not supporting a patient at the time of the event.The customer, a (b)(6) hospital, report that the freedom onboard battery did not hold a charge.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• 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 ; 5204541234
• MDR Report Key: 15375092
• Report Number: 3003761017-2022-00100
• Device Sequence Number: 5797280
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 10/31/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 295025-001
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2019
• 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