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

Device Problem Battery Problem (2885)

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

Event Date 08/15/2023

Event Type  malfunction  

Event Description

A battery was inserted into one of the two battery wells and the freedom driver immediately began fault alarming.The patient had previously been on the c2 and it was time to switch onto the freedom driver.This occurred inpatient.When the freedom driver was powered on, it immediately fault alarmed.The batteries inserted were fully charged.This is a second freedom driver application.The first time we transitioned off, it was because we were trying to assess whether or not the patients nausea and vomiting was being caused by the freedom driver.Nothing had been wrong with that freedom driver at that time.It is not a scheduled service interval.

• 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: 17892202
• MDR Text Key: 326031310
• Report Number: 3003761017-2023-00121
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male