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

Model Number 397002-001

Device Problems Battery Problem (2885); Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be evaluated by syncardia.The results will be provided in a follow-up mdr.

Event Description

While performing a routine evaluation, a syncardia technician reported that the companion 2 driver exhibited an emergency battery error alarm.

Manufacturer Narrative

Communication with the emergency battery was established and the smbus data was retrieved and reviewed.The battery evaluation observed no permanent faults that would indicate a malfunction of the emergency battery.The emergency battery was then subjected to a ten-minute battery discharge test.After 7 minutes the emergency battery became depleted and the driver's main buzzer alarmed.The emergency battery error alarm was then displayed.This confirmed the customer-reported issue.The root cause was determined to be a malfunction of the emergency battery.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5374 and ce 5504 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 (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 11582407
• MDR Text Key: 242731640
• Report Number: 3003761017-2021-00044
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• 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