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

Catalog Number 295025-001

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

The freedom onboard battery will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Event Description

The freedom onboard battery was not supporting a patient at the time of the event.The customer, a syncardia authorized distributor, reported that the freedom onboard battery did not charge.

Event Description

The freedom onboard battery was not supporting a patient at the time of the event.The customer, a syncardia authorized distributor, reported that the freedom onboard battery did not charge.

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom onboard battery s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Battery data review found data could only be retrieved by connecting battery to a power supply, indicating negative communication within the battery.Review also retrieved a permanent fault code.Visual inspection of external components found no abnormalities.Visual inspection of internal components not available for battery.Battery failed incoming inspection due to negative communication, gas gauge leds not illuminating when button pressed, and inability to charge.Additional testing was performed resulting in a permanent fault code indicating battery will not complete and/or hold a charge.Failure investigation for this complaint confirmed reported issue.The complaint was replicated during testing; root cause of freedom onboard battery not charging determined to be permanent fault within battery.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Battery was not in patient use at the time issue occurred.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.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: 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: 15332324
• MDR Text Key: 299167975
• Report Number: 3003761017-2022-00099
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 08/29/2022
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1