BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY

    MDR report key: 6907590 · Received October 2, 2017

    Report

    Report Number
    3003761017-2017-00175
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 7, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM HOSPITAL AC POWER SUPPLY WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE FREEDOM HOSPITAL AC POWER SUPPLY'S EXTERNAL COMPONENTS REVEALED A CHIP IN THE TRANSFORMER HOUSING NEAR A CORNER AND MISSING RUBBER FEET. INVESTIGATIONAL TESTING CONFIRMED THE CUSTOMER-REPORTED ISSUE. THE AC POWER SUPPLY FAILED TO LIGHT ITS OWN GREEN STATUS INDICATOR LED AND PROVIDED NO DC OUTPUT AT EITHER OPEN CIRCUIT OR WITH A FREEDOM DRIVER BEING USED AS A LOAD. VISUAL INTERNAL INSPECTION CONFIRMED THAT THE AC POWER SUPPLY WAS NOT FUNCTIONAL BECAUSE ONE OF COMPONENT L3'S (INDUCTOR) LEADS OF THE CIRCUIT INSIDE THE TRANSFORMER HOUSING WAS DETACHED FROM THE BOARD AT THE SOLDER WELD. THE ROOT CAUSE OF THE DAMAGE TO THE INTERNAL MAIN PRINTED CIRCUIT BOARD OF THE POWER SUPPLY IS UNKNOWN BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER; HOWEVER, THE DAMAGE TO L3 IS LIKELY THE RESULT OF A DROP OR OTHER ROUGH HANDLING, WHICH IS ALSO INDICATED BY THE DAMAGED CORNER TO THE TRANSFORMER HOUSING. 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 THE PATIENT BECAUSE IT DID NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. ADDITIONALLY, THE FREEDOM DRIVER HAS A REDUNDANT POWER SOURCE OF ONBOARD BATTERIES. THE FREEDOM HOSPITAL 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) INITIAL.

    Description of Event or Problem · 1

    THE FREEDOM HOSPITAL 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 HOSPITAL AC POWER SUPPLY WAS NO LONGER PROVIDING POWER WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS PROVIDED A NEW FREEDOM AC POWER SUPPLY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    THE FREEDOM HOSPITAL 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 HOSPITAL AC POWER SUPPLY WAS NO LONGER PROVIDING POWER WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS PROVIDED A NEW FREEDOM AC POWER SUPPLY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687143 SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY HOSPITAL AC POWER SUPPLY LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR