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

Catalog Number P/N 397002-001

Device Problem Insufficient Information (3190)

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

Event Date 05/21/2023

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Event Description

The distributor, a syncardia authorized distributor, reported companion 2 driver sent to ksa with batteries inside driver.Drivers were held in customs for >5days - when finally released the emergency battery was alarming upon plugging into main power.Driver was left plugged in for 7 days and emergency battery was still alarming.

• Brand Name: SYNCARDIA COMPANION 2 HOSPITAL 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: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 17083982
• MDR Text Key: 317547679
• Report Number: 3003761017-2023-00086
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P/N 397002-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2018
• 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