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

Model Number CSS CONSOLE

Device Problems Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2015

Event Type  malfunction  

Event Description

This css console was not supporting a patient.The customer reported that the monitoring laptop computer on the css console malfunctioned.This alleged failure mode poses a low risk to a patient because the issue was observed when the css console was not supporting a patient.In addition, it would not prevent the css console from performing its life-sustaining functions.The computer is a monitoring device only and does not control css console functionality.The css is returning to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

This css console was not supporting a patient.The customer reported that the monitoring laptop computer on the css console malfunctioned.The css console was returned to syncardia for evaluation.Review of the device history record confirmed that after the last service, the css console passed all functional and performance testing prior to being released to finished goods.The root cause of the customer-reported issue was a malfunction of the hard disk drive.This hard disk drive exhibited the same failure mode as previously-investigated computer hard disk drives.Previous investigations determined that the physical condition of the media in the hard disk drive degraded, ultimately leading to a laptop malfunction.This failure mode poses a low risk to a patient because the css console was not supporting a patient at the time the issue was observed.In addition, it would not prevent the css console from performing its life-sustaining functions.The computer and its operating system are used solely as a monitoring device and do not control the functionality of the css console.The hard disk drive was replaced and the css console was serviced and passed all functional and performance testing before being placed into finished goods.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 CIRCULATORY SUPPORT SYSTEM CONSOLE
• Type of Device: CSS CONSOLE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4898723
• MDR Text Key: 6833805
• Report Number: 3003761017-2015-00212
• 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,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: CSS CONSOLE
• Device Catalogue Number: 400207
• Device Lot Number: 29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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