BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4914845 · Received July 13, 2015

    Report

    Report Number
    2021710-2015-01186
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE EVALUATED THE UNIT, AND FOUND THAT THE EXPIRATORY FILTER WAS CRACKED. HE REPLACED THE FILTER AND TEST CIRCUIT, THEN PERFORMED OPERATIONAL VERIFICATION TESTING. THE UNIT WAS WORKING ACCORDING TO MFR SPECS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A UNIT THAT WAS ALARMING "CIRCUIT DISCONNECT" WHILE ON A PT. THE PT WAS REMOVED FROM THE UNIT AND PLACED ON ANOTHER VENTILATOR. THERE WAS NO HARM TO THE PT. CUSTOMER REQUESTED FIELD SERVICE TO ASSIST WITH CORRECTING THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452685 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE/ CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention