BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY

    MDR report key: 6186719 · Received December 19, 2016

    Report

    Report Number
    3003761017-2016-00398
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 8, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM HOSPITAL AC POWER SUPPLY WAS RETURNED TO SYNCARDIA FOR EVALUATION. EXTERNAL VISUAL INSPECTION OF THE FREEDOM HOSPITAL AC POWER SUPPLY REVEALED A DEPRESSED PIN IN THE HYPERTRONICS CONNECTOR. THE ROOT CAUSE OF THE PIN DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED BASED UPON THE INFORMATION PROVIDED IN THE CUSTOMER REPORT; HOWEVER, DAMAGE OF THIS NATURE TYPICALLY RESULTS FROM APPLYING EXCESSIVE FORCE TO THE CONNECTOR DURING THE MATING PROCESS WHEN AN OBSTRUCTION IS PRESENT IN THE CONNECTOR BARREL. FUNCTIONAL TESTING DETERMINED THAT FREEDOM HOSPITAL AC POWER SUPPLY CONFORMED TO ALL FUNCTIONAL TEST ACCEPTANCE CRITERIA; HOWEVER, THE UNIT DID NOT MEET THE MECHANICAL INSPECTION CRITERIA DUE TO THE DEPRESSED PIN IN THE HYPERTRONICS CONNECTOR. 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 THE ISSUE WAS OBSERVED WHEN THE FREEDOM HOSPITAL AC POWER SUPPLY WAS NOT SUPPORTING A PATIENT. THE FREEDOM HOSPITAL 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 HOSPITAL AC POWER SUPPLY IS A COMPONENT THAT ENABLES THE FREEDOM DRIVER TO BE PLUGGED INTO AN EXTERNAL POWER SOURCE. THE FREEDOM HOSPITAL AC POWER SUPPLY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM HOSPITAL AC POWER SUPPLY HAD A DEPRESSED PIN WHERE THE POWER SUPPLY CONNECTS INTO THE FREEDOM DRIVER AC POWER ADAPTOR.

    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 FREEDOM HOSPITAL AC POWER SUPPLY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM HOSPITAL AC POWER SUPPLY HAD A DEPRESSED PIN WHERE THE POWER SUPPLY CONNECTS INTO THE FREEDOM DRIVER AC POWER ADAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835785 SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY HOSPITAL AC POWER SUPPLY LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1