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

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

The patient had continous red alarm.

• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake rd; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e silverlake rd; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 17901756
• MDR Text Key: 326248706
• Report Number: 3003761017-2023-00135
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male