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

Model Number 595000-001

Device Problems Erratic or Intermittent Display (1182); Defective Component (2292)

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

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.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) initial.

Event Description

The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the display screen on the freedom driver did not work consistently.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.The driver in "as received" condition passed all required functional testing requirements, which included normotensive and hypertensive settings.Additionally, a display functionality test was performed, and the display performed as intended with no anomalies.The customer-reported issue was not reproduced during investigation testing and there was no evidence of a device malfunction.The root cause of the customer-reported issue cannot be conclusively determined.This issue will 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.

Event Description

The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the display screen on the freedom driver did not work consistently.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 7229350
• MDR Text Key: 98997253
• Report Number: 3003761017-2018-00043
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2018
• 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