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

Model Number 295025-001

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the reported issue did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of an ac power supply.The freedom onboard battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the freedom onboard battery gas gauge leds still showed a full charge after the freedom driver had been unplugged for approximately 1 hour while the patient ambulated.There was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection of the onboard battery revealed no anomalies.Review of the battery's system management (smbus) data did not find any recorded permanent faults.During functional testing, the battery passed all sections.During an extended observation run powering a freedom driver, the onboard battery displayed five lit leds after 46 minutes of operation.The onboard battery displayed four lit leds after 47 minutes of operation.During the test, the battery functioned as intended with no anomalies.The customer-reported issue could not be confirmed nor reproduced and there was no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• 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: 9267068
• MDR Text Key: 164681973
• Report Number: 3003761017-2019-00315
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 295025-001
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR