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

Model Number 397002-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited an unrecoverable high temperature alarm while supporting a patient.The patient was switched to a backup driver and there was no reported adverse patient impact.

Manufacturer Narrative

During investigation testing, the driver passed all sections of functional testing without any alarms or abnormalities.The customer-reported temperature alarm was not reproduced and the driver performed as intended.The root cause of the customer-reported issue could not be conclusively determined and there was no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az AZ 85713
• MDR Report Key: 9627273
• MDR Text Key: 177378553
• Report Number: 3003761017-2020-00025
• 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: 06/17/2020

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: 01/09/2020
• Initial Date Manufacturer Received: 12/29/2019
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 12/29/2019
• Supplement Dates FDA Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR