BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA

    MDR report key: 446786 · Received March 3, 2003

    Report

    Report Number
    2517967-2003-00027
    Event Type
    Malfunction
    Date Received
    March 3, 2003
    Date of Event
    August 1, 2002
    Report Date
    March 3, 2003
    Manufacturer
    DRAGER MEDICAL AG & CO. KGAA
    Product Code
    CBK
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE DEVICE IS A RENTAL VENTILATOR FROM A COMPANY, AND WAS NOT MADE AVAILABLE FOR EVAL BY DRAEGER MEDICAL, INC. AT ANY TIME. TWO BIOMED'S FROM THE RENTAL COMPANY, PERFORMED AN EVAL OF THE DEVICE AT THE USER FACILITY. THE EVAL NOTED THAT THE VOLUME READINGS POSTED BY THE DEVICE WERE NOT EQUAL TO THE USER DEFINED SETTINGS. A BIOMED PERFORMED A FLOW SENSOR CALIBRATION AND THE POSTED READINGS WERE WITHIN SPECS. A DEVICE CHECK WAS PERFORMED ON THE VENTILATOR AND THE VENTILATOR PERFORMED TO SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA * CBK DRAGER MEDICAL AG & CO. KGAA 2 DURA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *