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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the patient was outside in the heat and the freedom driver exhibited intermittent fault alarms while supporting the patient.The patient went inside and exchanged batteries and opened the bag so the driver could get air.Later in the evening, the patient reported that the freedom driver exhibited a continuous alarm.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.

Manufacturer Narrative

The customer-reported continuous alarm was not able to be reproduced and was not able to be confirmed during investigation testing.Only permanent alarms are recorded in the driver's alarm history, intermittent and/or recoverable alarms are not recorded.During investigation testing, the driver passed all sections of functional testing.Additionally, a 48-hour observation run was performed with no alarms.The driver performed as intended with no evidence of a device malfunction.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5269 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNUEMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 9967961
• MDR Text Key: 195731039
• Report Number: 3003761017-2020-00119
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR