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

Model Number 397002-001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver did not charge its internal battery despite being plugged in for several days.

Manufacturer Narrative

The customer-reported issue of the emergency battery not being able to charge was confirmed during review of the driver alarm history and reproduced during functional testing.The emergency battery was evaluated and found to have an unrecoverable permanent fault code of 4000.The fault code indicates the emergency battery was discharged beyond the point it could be recharged.The root cause of the emergency battery not being able to charge was an unrecoverable depletion of the emergency battery.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation 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: 8141555
• MDR Text Key: 129593474
• Report Number: 3003761017-2018-00550
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

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: 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: 11/30/2018
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 11/26/2018
• Supplement Dates FDA Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1