MAUDE Adverse Event Report: SYNCARDIA SYSTEMS INC C2 DRIVER; ARTIFICIAL HEART

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/28/2015

Event Type  malfunction  

Event Description

Primary c2 driver alarmed single compressor malfunction (high priority).Switched to backup c2 driver without any issues.

• Brand Name: C2 DRIVER
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS INC; 1992 e. silverlake rd.; tucson AZ 85713
• MDR Report Key: 5034317
• MDR Text Key: 24211423
• Report Number: 5034317
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Other Device ID Number: CONTROL #L154208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR