BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM HOME AC POWER SUPPLY

    MDR report key: 7121649 · Received December 15, 2017

    Report

    Report Number
    3003761017-2017-00252
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    December 5, 2017
    Report Date
    December 5, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FREEDOM HOME AC POWER SUPPLY WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION REVEALED TWO BROKEN STRAIN RELIEFS AND IT WAS ALSO NOTED THAT A COMPONENT WAS HEARD ROLLING AROUND INSIDE THE POWER BRICK. FUNCTIONAL TESTING DETERMINED THAT THE UNIT WOULD NO LONGER ILLUMINATE THE LED POWER INDICATOR AND THE UNIT WAS FOUND TO BE NON-OPERATIONAL. THE ROOT CAUSE OF THE MALFUNCTIONING AC POWER SUPPLY WAS DETERMINED TO BE THE DETACHMENT OF AN ELECTRICAL COMPONENT FROM THE PRINTED CIRCUIT BOARD INSIDE THE POWER BRICK. 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.

    Description of Event or Problem · 0

    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 NOT WORKING.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE THE REPORTED ISSUE WOULD NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER HAS A REDUNDANT POWER SOURCE OF 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). INITIAL.

    Description of Event or Problem · 1

    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 NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903029 SYNCARDIA FREEDOM HOME AC POWER SUPPLY AC POWER SUPPLY LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR