MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

The freedom driver has been 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 driver exhibited a fault alarm while supporting a patient.The patient was switched to a backup driver and there was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection of the external components revealed split housings and impact shock damage to the front housing.Visual inspection of the internal components revealed signs of impact shock on the main printed circuit board assembly (pcba) and on the housing's bosses and inserts, and a disconnected and skewed j2 ribbon cable.The driver's alarm history was reviewed and revealed a new alarm, a 34 fault code.This fault code alarm is likely the customer-reported alarm as it can occur due to intermittent power communication errors during an impact shock, power cycling of the driver or during onboard battery exchange.The driver passed all sections of functional testing.Additionally, an onboard battery exchange test was also performed utilizing nine functioning freedom onboard batteries.No alarms were produced during this test.During investigation testing, the customer-reported issue was not reproduced and there was no evidence of a device malfunction.The reported fault alarm was most likely caused by impact shock to the driver, temporarily causing an intermittent power connection.This power connection error would cause a permanent fault alarm to occur.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.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 9586380
• MDR Text Key: 175019536
• Report Number: 3003761017-2020-00010
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: 01/27/2020

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: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR