BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANESTHESIA DELIVERY UNIT

    MDR report key: 3231342 · Received July 15, 2013

    Report

    Report Number
    9610105-2013-00012
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BSZ
    PMA / PMN Number
    K050676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    AFTER THE CLINICIAN SWITCHED FROM VENT TO SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION (SIMV), THE PATIENT WAS NOT ABLE TO BE VENTILATED IN EITHER MECHANICAL OR MANUAL MODE. THE ANESTHESIA MACHINE WAS REBOOTED AND THE EVENT RECURRED. THE PATIENT REPORTEDLY DESATURATED. THE ANESTHESIA MACHINE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325733 ANESTHESIA DELIVERY UNIT ANESTHESIA GAS MACHINE BSZ GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention