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 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

The freedom onboard battery will be evaluated.The results will be provided in a follow-up mdr.

Event Description

During routine evaluation, a syncardia technician reported that the freedom onboard battery system management (smbus) data was not active without power, the charge indicator leds did not illuminate without power and the battery did not power a freedom driver.

Event Description

During routine evaluation, a syncardia technician reported that the freedom onboard battery system management (smbus) data was not active without power, the charge indicator leds did not illuminate without power and the battery did not power a freedom driver.

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 was reviewed as part of the battery testing.No failures were observed with the data itself, however negative communication was observed and data could only be retrieved by connecting battery to a power supply.Visual inspection of external components found no abnormalities.Visual inspection of internal components found no abnormalities.During incoming functional testing, battery failed for negative communication and because leds would not illuminate when button is pressed, indicating charge.Additional testing was performed to test if battery could hold a charge and power a driver.Leds illuminated normally while on charger indicating full charge.Leds would not illuminate when removed from charger and battery would not hold charge or power driver, confirming customer complaint.Failure investigation for this complaint confirmed the reported issue.Testing of the freedom onboard battery corroborated customer complaint that the battery was not charging and was unable to power the driver.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Battery was not in use by a patient at the time of complaint.

• 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: 15651930
• MDR Text Key: 302405462
• Report Number: 3003761017-2022-00113
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• 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