BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM AC POWER SUPPLY

    MDR report key: 5642483 · Received May 9, 2016

    Report

    Report Number
    3003761017-2016-00188
    Event Type
    Malfunction
    Date Received
    May 9, 2016
    Date of Event
    April 28, 2016
    Report Date
    April 28, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS FREEDOM HOSPITAL AC POWER SUPPLY EU WAS NOT IN PATIENT USE. THE FREEDOM HOSPITAL AC POWER SUPPLY EU IS A COMPONENT THAT ENABLES THE FREEDOM DRIVER TO BE PLUGGED INTO AN EXTERNAL POWER SOURCE. THE CUSTOMER REPORTED THAT THE GREEN CONNECTOR ON THE HOSPITAL AC POWER SUPPLY EU COULD NOT CONNECT TO ANY FREEDOM POWER ADAPTORS OR BATTERY CHARGERS. THE HOSPITAL AC POWER SUPPLY EU WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE CABLE CONNECTOR COVER WAS NOT IN THE CORRECT ORIENTATION. THIS PREVENTED THE HOSPITAL AC POWER SUPPLY EU FROM MAKING A PROPER CONNECTION TO PROVIDE POWER TO A FREEDOM POWER ADAPTOR OR BATTERY CHARGER. THE AC POWER SUPPLY CABLE WAS DISASSEMBLED, THE CONNECTOR KEY SLOT WAS ALIGNED WITH THE CONNECTOR COVER KEY TAB AND THE CORRECT MATING CONFIGURATION WAS OBTAINED. AFTER THE AC POWER SUPPLY CABLE WAS REASSEMBED, THE HOSPITAL AC POWER SUPPLY EU PASSED ALL REQUIRED FUNCTIONAL TESTING. THE ROOT CAUSE FOR THE OBSERVED ISSUE WAS THE INCORRECT ORIENTATION OF THE CONNECTOR COVER ON THE FREEDOM HOSPITAL AC POWER SUPPLY EU, WHICH MAY RESULT FROM PROCESSES AT THE COMPONENT SUPPLIER OR SYNCARDIA. SYNCARDIA HAS IMPLEMENTED PROCESS CONTROLS TO IDENTIFY THIS ISSUE PRIOR TO RELEASE OF FREEDOM AC POWER SUPPLIES TO FINISHED GOODS AND TO ELIMINATE THE POTENTIAL FOR RECURRENCE. THE OCCURRENCE RATE FOR THIS ISSUE IS EXTREMELY LOW AND THERE IS NO IMPACT TO THE PATIENT. THE INCORRECT ORIENTATION OF THE CONNECTOR COVER IS IMMEDIATELY IDENTIFIABLE BY HOSPITAL PERSONNEL WHEN PREPARING THE FREEDOM DRIVER FOR PATIENT USE PER SECTION 7.5 OF F-900013-EN, FREEDOM DRIVER SYSTEM OPERATOR MANUAL. THE FREEDOM DRIVER SYSTEM INCLUDES MULTIPLE POWER SOURCES AND POWER SUPPLY ACCESSORIES SUCH THAT OPERATION OF THE DRIVER IS NOT IMPACTED BY THIS ISSUE. 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.

    Description of Event or Problem · 1

    THIS FREEDOM HOSPITAL AC POWER SUPPLY EU WAS NOT IN PATIENT USE. THE FREEDOM HOSPITAL AC POWER SUPPLY EU IS A COMPONENT THAT ENABLES THE FREEDOM DRIVER TO BE PLUGGED INTO AN EXTERNAL POWER SOURCE. THE CUSTOMER REPORTED THAT THE GREEN CONNECTOR ON THE HOSPITAL AC POWER SUPPLY EU COULD NOT CONNECT TO ANY FREEDOM POWER ADAPTORS OR BATTERY CHARGERS. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THIS ISSUE WAS OBSERVED WHEN THE FREEDOM HOSPITAL AC POWER SUPPLY EU WAS NOT IN USE BY A PATIENT. IN ADDITION, THE REPORTED ISSUE WOULD NOT PREVENT A FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER HAS A REDUNDANT POWER SOURCE OF ONBOARD BATTERIES. THE FREEDOM HOSPITAL AC POWER SUPPLY EU WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294870 SYNCARDIA FREEDOM AC POWER SUPPLY AC POWER SUPPLY LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1