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

Catalog Number 295600-001

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.In addition, the freedom driver has a redundant power source of multiple onboard batteries.The freedom home ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

Tha freedom home ac power supply was not in patient use.The freedom home 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 home ac power supply was damaged where the cord is inserted and wires were exposed.

Manufacturer Narrative

Visual inspection confirmed the customer-reported issue as the bend relief was found to be damaged with exposed wiring and the power brick was damaged at the edges.It cannot be conclusively determined what caused this damage to the bend relief, but it is likely that it was caused by an excessive amount of tension being applied to the power source, toward the plug end.During investigation testing, the power supply met all functional acceptance criteria.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 5035 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM HOME AC POWER SUPPLY
• Type of Device: EXTERNAL POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 9298524
• MDR Text Key: 165983199
• Report Number: 3003761017-2019-00324
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295600-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR