BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVITA

    MDR report key: 446588 · Received March 6, 2003

    Report

    Report Number
    2517967-2003-00031
    Event Type
    Other
    Date Received
    March 6, 2003
    Date of Event
    February 12, 2003
    Report Date
    March 6, 2003
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD BREATHING PROBLEMS INITIALLY AND WAS PROVIDED SURFACTANT AND INTUBATED. THE PATIENT WAS LATER EXTUBATED, WEANED, AND THEN VENTILATED USING A NASAL PRONG AND A CPAP OF 3 CMH20 AT A FIO2 OF 5O%. THE CPAP WAS LATER INCREASED TO 5 CMH20. THE PATIENT WAS REPORTED TO HAVE DEVELOPED A PNEUMOTHORAX WHILE IN CPAP MODE. THE PATIENT WAS PLACED INTO AN OXYGEN TENT AND LATER RECOVERED FROM THE PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA CONTINUOUS VENTILATOR CBK DRAEGER MEDICAL, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other