MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA CSS CONSOLE MONITOR; EXTERNAL PNEUMATIC DRIVER MONITOR

Model Number CSS CONSOLE

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Power Up (1476)

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

Event Date 03/20/2015

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 failed to boot up and the screen "froze".This alleged failure mode poses a low risk to the 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.

Manufacturer Narrative

The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

This css console at the customer location was not supporting a patient.The customer reported that the css console's computer monitor was not working during checkout.Syncardia shipped another monitor to the customer who hooked it up to the console and returned the non-working one to syncardia.The evaluation revealed that the computer had a malfunctioning hard drive.The customer reported issue poses a low risk to a patient because the issue was observed when the css console was not supporting a patient.In addition, the issue 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 hard drive in the laptop was replaced, and installed into css console 2.The css console was tested and passed the console validation protocol 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 CSS CONSOLE MONITOR
• Type of Device: EXTERNAL PNEUMATIC DRIVER MONITOR
• 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: 4703991
• MDR Text Key: 5726188
• Report Number: 3003761017-2015-00115
• 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: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• 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: 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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