BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM HOME AC POWER SUPPLY

    MDR report key: 6141099 · Received December 2, 2016

    Report

    Report Number
    3003761017-2016-00376
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 11, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM HOME AC POWER SUPPLY WAS RETURNED TO SYNCARDIA FOR EVALUATION. INVESTIGATION TESTING CONFIRMED THE CUSTOMER-REPORTED ISSUE AND VERIFIED THAT THE FREEDOM HOME AC POWER SUPPLY HAS AN INTERNAL ELECTRICAL PROBLEM THAT AFFECTS THE OUTPUT VOLTAGE REGULATION. HOWEVER, BECAUSE THE FREEDOM HOME AC POWER SUPPLY IS AN OFF-THE-SHELF COMPONENT, NO FURTHER MECHANICAL DISASSEMBLY OR ELECTRICAL DIAGNOSTIC TESTS WERE PERFORMED BY SYNCARDIA. THE UNIT WILL BE RETURNED TO THE SUPPLIER FOR ROOT CAUSE ANALYSIS. THE RESULTS OF THE SUPPLIER EVALUATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FREEDOM AC POWER SUPPLY WAS RETURNED TO THE SUPPLIER FOR ROOT CAUSE ANALYSIS. THE ROOT CAUSE OF THE MALFUNCTION WAS DETERMINED TO BE A LEAKY DIODE DESIGNATOR D6. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOM EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 2.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM HOME AC POWER SUPPLY HAD A POOR CONNECTION, IT DID NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. IN ADDITION, 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

    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 PATIENT'S FREEDOM HOME AC POWER SUPPLY HAD A POOR CONNECTION. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    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 PATIENT'S FREEDOM HOME AC POWER SUPPLY HAD A POOR CONNECTION. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    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 PATIENT'S FREEDOM HOME AC POWER SUPPLY HAD A POOR CONNECTION. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794116 SYNCARDIA FREEDOM HOME AC POWER SUPPLY AC POWER SUPPLY LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR