MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Model Number 397002-001

Device Problems Image Display Error/Artifact (1304); Battery Problem (2885)

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

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be evaluated by syncardia.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

While performing a routine evaluation, a syncardia technician reported that the companion 2 driver exhibited the wrong user interface boot-up screen.

Manufacturer Narrative

Visual inspection of the driver revealed no anomalies that would indicate a device malfunction.The patient data files were reviewed and revealed ten system malfunction alarms which can occur if there is an issue during initialization of the embedded supervisors during driver boot-up.A driver booting up to the bios screen could be an indication that the 3-volt battery is not providing enough power to the mainboard to maintain the bios programming.During investigation testing, the 3-volt battery was found to be depleted.A known functioning 3-volt battery was installed and the driver displayed the correct user interface boot-up screen.The 3-volt battery is required to be replaced at every 2-year service.When this driver was received and tested, it was approximately 1 month overdue for 2-year service.Functional testing was then performed on the driver and an issue was found with the emergency battery, which was unrelated to the reported issue.The root cause of the reported wrong user interface boot-up screen was determined to be a depleted 3-volt battery.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 5226 (b)(4), follow-up report 1.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 9838177
• MDR Text Key: 183979423
• Report Number: 3003761017-2020-00084
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• 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