MAUDE Adverse Event Report: SYNCARDIA SYSTEMS INC SYNCARDIA; TOTAL ARTIFICIAL HEART CONSOLE; NON-IMPLANTABLE DEVICE

Device Problem Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2018

Event Type  malfunction  

Event Description

Transport of a patient on a total artificial heart to the or for transplant.Prior to transport 30 min battery life as evidenced by 3 of 4 bars.Device suddenly shut off.Device checked & plugged into an a/c outlet and resumed functioning.Device off for approximately 10 to 15 seconds and was later sequestered.

• Brand Name: SYNCARDIA
• Type of Device: TOTAL ARTIFICIAL HEART CONSOLE; NON-IMPLANTABLE DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS INC; 1992 east silverlake road; tucson AZ 85713
• MDR Report Key: 8270519
• MDR Text Key: 133856953
• Report Number: 8270519
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA