BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S/5 ADU CARESTATION

    MDR report key: 2890693 · Received December 26, 2012

    Report

    Report Number
    9610105-2012-00046
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 11, 2012
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BSZ
    PMA / PMN Number
    K050676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER EUROPEAN LAW, PT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. 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

    THE CUSTOMER REPORTED THE VENTILATOR STOPPED APPROXIMATELY 5 MINUTES AFTER THE PT HAD BEEN CONNECTED. THE CUSTOMER REPORTEDLY NOTED A STRAIGHT CO2 LINE, AND THE SPO2 LEVEL WAS 58%. THE DESATURATION WAS RESOLVED BY SWITCHING TO MANUAL MODE OF VENTILATION. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/5 ADU CARESTATION ANESTHESIA GAS MACHINE BSZ GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention