BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTA XL

    MDR report key: 886208 · Received July 25, 2007

    Report

    Report Number
    1220063-2007-00016
    Event Type
    Death
    Date Received
    July 25, 2007
    Date of Event
    June 26, 2007
    Report Date
    July 23, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM A CUSTOMER THAT AN ADVERSE EVENT OCCURRED WHICH INVOLVED OUR DELTA XL MONITOR NETWORKED TO OUR MULTIVIEW WORKSTATION. THE CUSTOMER REPORTED THAT AT 7.42 PM, THE PATIENT GOT OUT OF BED AND THE ECG LEAD SET DISCONNECTED FROM THE MULTIMED POD. THE CUSTOMER INDICATED THAT THE DELTA XL MONITOR AND THE MULTIVIEW WORKSTATION (MVWS) AUDIBLY AND VISUALLY ALARMED FOR AN "ECG LEADS INVALID" ADVISORY ALARM. THE NURSING STAFF WAS ALSO ALERTED REMOTELY ON ANOTHER MONITOR OF THE ADVISORY ALARM. IN ADDITION, THE ARTERIAL LINE THAT WAS INSERTED IN THE PATIENT WAS DISLODGED AND THE PATIENT STARTED TO BLEED OUT, THE PATIENT APPARENTLY THEN WENT INTO CARDIAC ARREST. THE PATIENT WAS REVIVED, BUT EXPIRED AFTER SEVERAL DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA XL DELTA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS13476 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Death