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

Catalog Number 397002-001

Device Problem Battery Problem (2885)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver would not recognize the inserted batteries, even though both batteries tested full when the fuel gauge on the battery was pressed.Additionally there was no icon of a plug on the screen when the companion 2 driver was plugged into wall power.Alternate batteries were inserted and the same issue occurred.

Manufacturer Narrative

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

• 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: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16414850
• MDR Text Key: 310010571
• Report Number: 3003761017-2023-00016
• Device Sequence Number: 1
• Product Code: LOZ
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2019
• 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