BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AESTIVA 7900

    MDR report key: 3012458 · Received March 15, 2013

    Report

    Report Number
    2112667-2013-00005
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 4, 2013
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K973896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT, DURING THE FIRST CASE OF THE DAY, THE CLINICIAN NOTED THE VENTILATOR WOULD NOT WORK IN PRESSURE AND VOLUME MODES. OTHER FACTORS WITH THE PT REPORTEDLY MADE IT UNCLEAR WHETHER THE DIFFICULTIES WITH VENTILATING WERE DUE TO THE PT OR THE VENTILATOR. THE SURGICAL PROCEDURE REQUIRED THAT THE PT TOLERATE FULL HEAD FLEXION OR FULL EXTENSION. THE PT REPORTEDLY IS AN INFANT AND HAD A VERY SHORT TRACHEAL SEGMENT. THIS RESULTED IN OCCURRENCES OF THE PT BEING "MAINSTEMMED" AS WELL AS EXTUBATED DURING THE PROCEDURE AND REQUIRED REPOSITIONING OF THE ENDOTRACHEAL TUBE. FOLLOWING REPOSITIONING, THE CLINICIAN REPORTEDLY SWITCHED TO MECHANICAL VENTILATION MODE AND NO VOLUME WAS MEASURED ON THE VENTILATOR. THE FLOW SENSOR WAS REPLACED AND THE EXPECTED READINGS WERE DISPLAYED ON THE VENTILATOR. THE CUSTOMER REPORTED THE PT SUFFERED "MILD DESATURATION" (IN THE 70S) DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110544 AESTIVA 7900 ANESTHESIA MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention