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

Model Number	295025-001
Medical Device Problem Codes	Battery Problem (2885); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
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.Ce 5735 (2 of 2) initial.
Event or Problem Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2022-00001 and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2022-00002).The customer, a syncardia certified hospital, reported that the patient was at home when the freedom driver started overheat and exhibited an alarm.The patient also reported that he exchanged the freedom driver onboard batteries and the driver stopped alarming.The patient put the freedom onboard batteries, that were in the driver, into the battery charger and reported they would not fully charge.There was no reported adverse patient impact.
Additional Manufacturer Narrative
The freedom onboard battery was evaluated per the freedom onboard battery evaluation procedure and passed all sections.During investigation testing, there was no evidence of a device malfunction and the batteries performed as intended.The freedom driver and freedom battery charger used at the time of the reported issue were not returned and therefore could not be included in this investigation.The root cause of the customer-reported freedom driver alarm when the freedom onboard battery was inserted could not be conclusively determined.This issue will be tracked and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.Ce 5735 (b)(4) follow-up report 1 (2 of 2).

• 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: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 13214910
• Report Number: 3003761017-2022-00002
• Device Sequence Number: 14793622
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• 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): Unknown
• 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): 07/28/2022

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 Model Number: 295025-001
• 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): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2019
• 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 Age: 47 YR
• Patient Sex: Male