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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); Output Problem (3005)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be evaluated by syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

While performing a routine evaluation, a syncardia technician reported that the freedom driver did not reach the specified beat rate values.

Manufacturer Narrative

Visual inspection of the external components revealed that the driver was returned without the issued power adaptor.Visual inspection of the internal components revealed coating anomalies around the beat rate adjuster/potentiometer and elsewhere on the main printed circuit board assembly (pcba).Additionally, the top-left main board mounting screw was stripped out from the post in the left battery post, fusing the main board.Due to these observations, the main pcba was suspected to be faulty.During investigation testing, the main pcba was replaced with a known functioning main pcba.The freedom driver was retested and passed all test steps.The root cause of the reported issue of the freedom driver unable to reach the specified beat rate values was determined to be a malfunction of the main pcba.This issue will be tracked and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.Ce 5270 comp (b)(4) follow-up report 1.

• 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 (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 9967960
• MDR Text Key: 194807589
• Report Number: 3003761017-2020-00120
• 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: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2017
• 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