MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE; CIRCULATORY ASSIST DEVICE

Model Number CSS CONSOLE

Device Problems Device Inoperable (1663); Computer Operating System Problem (2898)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

The customer reported that the monitoring laptop computer on the css console "crashed," while supporting a pt.A replacement laptop computer was shipped to the customer and was installed onto the css console.The customer confirmed that the replacement laptop computer booted up and that the css console performed as intended.The laptop computer that was removed from the css console was returned to syncardia for eval.Testing revealed that the root cause of the reported issue was a malfunction of the laptop's hard drive.The issue was resolved by replacing the hard drive.Testing confirmed that the css console booted up and functioned as intended.

Manufacturer Narrative

This issue posed a low risk to the pt because the pt was switched to the backup driver without any adverse impact.This issue will continue to be monitored through the customer experience process.Syncardia has completed its eval of this complaint and is closing this file.

• Brand Name: SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp regulator ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4360760
• MDR Text Key: 16545057
• Report Number: 3003761017-2014-00277
• Device Sequence Number: 1
• Product Code: LOZ
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/18/2014

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: Other
• Device Model Number: CSS CONSOLE
• Device Catalogue Number: 400207
• Device Lot Number: 13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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
• Patient Age: 49 YR