MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE; EXTERNAL PNEUMATIC DRIVER

Model Number CSS CONSOLE

Device Problems Failure to Power Up (1476); Computer Operating System Problem (2898)

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

Event Date 02/16/2016

Event Type  malfunction  

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 takes 10 minutes to boot up.The customer also reported that the laptop exhibited grinding noises.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 laptop computer was removed from the css console and will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

The laptop computer was removed from the css console and was returned to syncardia for evaluation.The laptop computer was installed into a css console.Immediately after turning on the laptop computer, the hard disk drive began to make a whining, scratchy noise, which subsided after approximately 15 minutes.The boot up took several minutes, which confirmed the report by the customer.The laptop computer did not exhibit any failure modes or issues other than the noise while testing was being performed.The investigation determined that the root cause of the reported issue was a malfunction of the hard disk drive.This hard disk drive exhibited the same failure mode as previously-investigated computer hard drives.Previous investigations determined that the physical condition of the media in the hard disk drive had degraded.An electronic failure of the hard disk drive damaged the read/write head(s), which ultimately leads to laptop computer malfunction.The hard disk drive was replaced.Laptop boot up time improved to less than two minutes, and no abnormal noises were heard from the laptop computer.The css console passed all testing, and the laptop computer performed as intended.This failure mode posed 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.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).

Event Description

This css console was not supporting a patient.The customer reported that the monitoring laptop computer on the css console took 10 minutes to boot up.The customer also reported that the laptop exhibited grinding noises.

• Brand Name: SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake rd.; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5451914
• MDR Text Key: 39216368
• Report Number: 3003761017-2016-00069
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSS CONSOLE
• Device Catalogue Number: 400207
• Device Lot Number: 5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2007
• 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