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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

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) (1 of 2).

Event Description

The freedom driver was not supporting a patient.The reported issue is reported under two separate medical device reports: (1) freedom driver s/n (b)(4) (mfr report # 3003761017-2019-00014) and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2019-00015).The customer, a syncardia certified hospital, reported that they were preparing a freedom driver s/n (b)(4) for a patient and the driver alarmed and then shut off.The customer also indicated the freedom onboard battery s/n (b)(4) may have caused the fault alarm.

Manufacturer Narrative

The customer-reported issue of a fault alarm upon startup was confirmed and was reproduced during investigation testing.The customer-reported issue of the driver shutting off after the alarm sounding was not able to be confirmed or reproduced during investigation testing.The root case was determined to be malfunction of the u31 pressure sensor on the driver's main printed circuit board assembly (pcba).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.Ce 4635 follow-up report 1 (1 of 2).

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8277587
• MDR Text Key: 136146710
• Report Number: 3003761017-2019-00014
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• 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: 01/16/2019
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1