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

Model Number 295025-001

Device Problem Battery Problem (2885)

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

Event Date 10/30/2020

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.(b)(4); initial.

Event Description

The customer from a syncardia certified hospital reported that the freedom onboard battery showed full charge, but the freedom driver exhibited an alarm when the battery was inserted.There was no reported adverse patient impact.

Manufacturer Narrative

The freedom onboard battery successfully passed all functional testing including a discharge test which is used to evaluate the onboard battery's capacity.In addition, the freedom onboard battery was fully charged and inserted into a known functioning freedom driver as the freedom driver used by the patient at the time of the reported issue was not returned and therefore could not be included in this investigation.The freedom onboard battery powered the driver for 30 minutes without any errors or alarms.This test was repeated three times.The battery continued to power the driver with no abnormalities or alarms during each test.The root cause of the customer-reported issue could not be determined.The freedom onboard battery performed as intended with no evidence of a device malfunction.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5404 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 10846356
• MDR Text Key: 216920125
• Report Number: 3003761017-2020-00229
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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: Lay User/Patient
• Device Model Number: 295025-001
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR