BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM HOME AC POWER SUPPLY

    MDR report key: 6186792 · Received December 19, 2016

    Report

    Report Number
    3003761017-2016-00402
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 9, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM HOME AC POWER SUPPLY WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE FREEDOM HOME AC POWER SUPPLY PASSED ALL FUNCTIONAL TESTS. THE CUSTOMER-REPORTED ISSUE CONCERNING AN INOPERABLE GREEN LED INDICATOR LIGHT COULD NOT BE REPRODUCED DURING INVESTIGATION TESTING; THEREFORE, A ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THIS ISSUE WAS OBSERVED WHEN THE FREEDOM HOME AC POWER SUPPLY WAS NOT IN USE BY A PATIENT. IN ADDITION, 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).

    Description of Event or Problem · 1

    THIS 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 GREEN LED LIGHT ON THE FREEDOM HOME AC POWER SUPPLY WOULD NOT LIGHT UP.

    Description of Event or Problem · 1

    THIS 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 GREEN LED LIGHT ON THE FREEDOM HOME AC POWER SUPPLY WOULD NOT LIGHT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836365 SYNCARDIA FREEDOM HOME AC POWER SUPPLY FREEDOM HOME AC POWER SUPPLY LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1