BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM AC POWER SUPPLY

    MDR report key: 6112609 · Received November 18, 2016

    Report

    Report Number
    3003761017-2016-00372
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 10, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM AC POWER SUPPLY WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE FREEDOM AC POWER SUPPLY REVEALED A BROKEN STRAIN RELIEF, A MISSING CONNECTOR O-RING AND A DAMAGED HYPERTRONICS CONNECTOR. FOREIGN ADHESIVE/TAPE WAS FOUND ON THE STRAIN RELIEF, INDICATING AN ATTEMPTED REPAIR OF THE POWER CORD ON THE FREEDOM AC POWER SUPPLY. UNAUTHORIZED REWORK ON THE FREEDOM DRIVER OR ANY OF THE RELATED ACCESSORIES IS PROHIBITED. WHILE THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED, BASED UPON THE DAMAGE OBSERVED AND THE EVIDENCE OF ATTEMPTED REPAIR, IT CAN BE CONCLUDED THE FREEDOM AC POWER SUPPLY WAS SUBJECTED TO IMPROPER USE INCLUDING ROUGH HANDLING AND UNAUTHORIZED REWORK THE FREEDOM AC POWER SUPPLY PROVIDED THE PROPER OUTPUT VOLTAGE AND OPERATED AS INTENDED FOR POWER DELIVERY. 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 ALTHOUGH THE FREEDOM AC POWER SUPPLY CORD HAD FRAYED, 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 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 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 POWER CORD ON THE PATIENT'S FREEDOM AC POWER SUPPLY HAD FRAYED. THE PATIENT WAS PROVIDED A BACK-UP FREEDOM AC POWER SUPPLY, AND THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    THE FREEDOM 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 POWER CORD ON THE PATIENT'S FREEDOM AC POWER SUPPLY HAD FRAYED. THE PATIENT WAS PROVIDED A BACK-UP FREEDOM AC POWER SUPPLY, AND THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764060 SYNCARDIA FREEDOM AC POWER SUPPLY FREEDOM AC POWER SUPPLY LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR