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

Model Number 295025-001

Device Problems Battery Problem (2885); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom onboard battery was returned from the field for evaluation and failed op 030 for functional evaluation in accordance with mfg-191, freedom onboard battery evaluation procedure.Led's did not illuminate and smbus data did not display unless put into the charger.Also the battery could not be discharged for storage.This was not an out of box failure.Results of the investigation showed signs of impact shock on the right side of the holding tab of the freedom onboard battery.As a part of the investigation, a second evaluation of the battery was performed in accordance with mfg-191, freedom onboard battery evaluation procedure.The functional evaluation found a failure to activate the smbus data by battery power.The smbus data was activated only when external power was connected and it showed that the battery had an unspecified permanent fault, likely as a result of impact shock.Syncardia has completed its evaluation of this complaint and is closing this file.If new or additional information is received in the future, syncardia will file a follow up mdr.(b)(4).

Event Description

While performing routine freedom onboard battery evaluation, a syncardia technician reported that the onboard battery gas gauge leds did not illuminate, smbus data did not display if not put into the charger, and the battery could not be discharged for storage.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, az ; 5451234120
• MDR Report Key: 9741981
• MDR Text Key: 181547277
• Report Number: 3003761017-2020-00067
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 295025-001
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2018
• 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