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

Model Number 397002-001

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver was in a store room and not plugged into wall power.When the driver was turned on for a training session, the driver exhibited an emergency battery error alarm.

Manufacturer Narrative

The driver's patient file was reviewed and revealed ten emergency battery error alarms thus confirming the customer-reported issue.The root cause was determined to be malfunction of the emergency battery as it was unable to power the driver for the full 10-minute requirement.The inability to power the system for the required duration is a result of loss of battery capacitance.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(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
• MDR Report Key: 10477304
• MDR Text Key: 205493789
• Report Number: 3003761017-2020-00172
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1