BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARFUSION

    MDR report key: 3982612 · Received June 16, 2014

    Report

    Report Number
    2021710-2014-00031
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN DISTRIBUTOR DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO PROVIDED BY THE FOREIGN DISTRIBUTOR. THE FOLLOWING CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO PROVIDED BY THE FOREIGN DISTRIBUTOR. THE FOREIGN DISTRIBUTOR'S REP EVALUATED THE DEVICE AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAILED GAS DELIVERY ENGINE (GDE). ON (B)(4), CAREFUSION SENT A REPLACEMENT GAS DELIVERY ENGINE TO THE DISTRIBUTOR FOR THEM TO REPAIR AND RETURN THIS DEVICE TO AN IN USE CONDITION. CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE FOREIGN DISTRIBUTOR IN ARGENTINA FOR THE RETURN OF THE ALLEGED FAULTY GAS DELIVERY ENGINE FOR EVAL. AS OF (B)(4) 2014, THE ALLEGED FAULTY GAS DELIVERY ENGINE HAS NOT BEEN RECEIVED. SHOULD THE ALLEGED FAULTY GAS DELIVERY ENGINE BE RECEIVED FOR EVAL. CAREFUSION WILL SUBMIT A F/U MEDWATCH REPORT. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO AN E-MAIL FROM THE FOREIGN DISTRIBUTOR. "OUR DEALER CLAIMS THE FIO2% CHANGES TO 100% BY ITSELF REGARDLESS OF THE SETTING, IN ORDER TO CORRECT THIS PROBLEM THE VENTILATOR HAS TO BE POWER DOWN AND BACK ON AND STARTS TO DELIVER THE CORRECT FIO2 ACCORDING TO THE SETTING, INSTRUCTED OUR DEALER TO CHECK THE FIO2 CELL CONNECTOR AND THERE NO PROBLEMS FOUND WITH THE CONNECTOR". THE FOLLOWING ADD'L INFO CONCERNING THE EVENT WAS DOCUMENTED BY A CAREFUSION TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO AN E-MAIL FROM THE FOREIGN DISTRIBUTOR. "ADD'L INFO WAS PROVIDED BY OUR DEALER REGARDING THIS ISSUE, THEY CLAIM THEY FOUND THE PROBLEM WHILE PERFORMING A P.M. ON THIS VENTILATOR. THEY WERE INFORMED BY THE CUSTOMER OF THIS ISSUE BEFORE THE P.M. OUR DEALER CLAIMS THERE WAS NO FIO2 ALARMS, VENTILATOR WAS SET TO DEFAULTS SETTINGS. THEY HAD AN EXTERNAL FIO2 ANALYZER CONNECTED TO THE VENTILATOR AND THE READINGS ON IT MATCH THE VENTILATOR FIO2% 100%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353533 CARFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION AVEA CLIO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA