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

Catalog Number 295600-002

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the device was not in patient use.The freedom home 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 home ac power supply was not in patient use.The freedom home ac power supply is a power supply unit which has an integrated, molded wall input power cord.The home ac power supply connects the power adaptor to a wall power outlet.The customer, a syncardia certified hospital, reported that the freedom driver home ac power supply had a twisted green connector and needed repair.

Manufacturer Narrative

The customer-reported twisted connector was confirmed during visual inspection as the ac power supply's connector outer housing was oriented improperly.The root cause of the improperly oriented connector cannot be conclusively determined.The ac power supply was shipped from syncardia meeting all final acceptance criteria which includes a properly positioned connector housing.Syncardia labeling does not instruct users to remove or service this component for any reason.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.(b)(4) 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: 8937107
• MDR Text Key: 159641530
• Report Number: 3003761017-2019-00253
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295600-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1