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

Catalog Number 295600-002

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver is also equipped with redundant power sources, including multiple rechargeable freedom onboard batteries and an external battery charger which provide additional means of mitigating the impact to patient care in the event that the power supply exhibits an issue.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

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 was "not working" while supporting a patient.The freedom home ac power supply was exchanged for an alternate power supply.There was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection of the power supply revealed missing feet on the power brick and exposed threads on the connector assembly.During investigation testing, the power supply was unable to power a freedom driver.Further inspection of the connector assembly revealed that the internal portion of the connector was loose and therefore was not properly oriented when connection to the freedom power adapter was attempted.This prevented the power supply from making a proper electrical connection and confirmed the customer-reported issue of the power supply not working.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 4855 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM HOME 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: 8746427
• MDR Text Key: 149675844
• Report Number: 3003761017-2019-00183
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/27/2019
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR