MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM AC POWER SUPPLY

Catalog Number 295050-001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because this issue did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of onboard batteries.The freedom ac power supply has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the freedom ac power supply was not working; the led light did not illuminate when inserted in the patient's freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

The customer-reported issue of the freedom ac power supply not able to supply power to the freedom driver was confirmed during the functional evaluation; the ac power supply was unable to pass current to the driver.The root cause of the reported issue cannot be determined without physical access to the internal printed circuit board.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM AC POWER SUPPLY
• Type of Device: AC POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8113014
• MDR Text Key: 129176365
• Report Number: 3003761017-2018-00542
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR