BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCD7000

    MDR report key: 2494289 · Received March 12, 2012

    Report

    Report Number
    1220063-2012-00020
    Event Type
    Death
    Date Received
    March 12, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 17, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, A PT WAS TRANSPORTED FROM THE ICU TO RADIOLOGY FOR A CT SCAN. THE BEDSIDE SC7000 WAS REMOVED FROM THE DOCKING STATION IN THE ICU AND OPERATED ON BATTERY TO TRANSPORT THE PT FOR THE CT SCAN. IT WAS REPORTED THAT THE PT WAS PLACED IN THE CT MACHINE AND THE CT SCAN WAS STARTED. ALL STAFF EXITED THE ROOM AND CLOSED THE DOOR DURING THE CT SCAN. AFTER COMPLETION OF THE CT SCAN, THE STAFF RE-ENTERED THE ROOM AND IMMEDIATELY NOTICED THAT THE SC7000 MONITOR WAS OFF. THIS WAS REPORTEDLY 25 MINUTES AFTER THE SC7000 WAS REMOVED FROM THE IDS AND THE TRANSPORT WAS BEGUN. THE STAFF TRIED TO TURN THE SC7000 BACK ON, BUT IT WOULD NOT POWER UP. THE PT WAS REMOVED FROM THE CT MACHINE AND TRANSFERRED TO THE BED. IT WAS REPORTED THAT THE PT BECAME BLUE AND BEGAN AGONALLY BREATHING. THE PT REPORTEDLY BECAME GRAY AND A CRASH CART WAS BROUGHT IN. WHEN PLACED ON THE CRASH CART MONITOR, THE PT WAS REPORTEDLY ASYSTOLE. MEDICATION WAS DELIVERED, CPR WAS STARTED AND A CODE BLUE WAS CALLED. THE PT COULD NOT BE REVIVED AND EXPIRED 42 MINUTES AFTER THE MONITOR WAS FOUND TO BE POWERED OFF. THE HOSPITAL BIOMEDICAL TECHNICIAN EXAMINED THE SC7000 MONITOR AND REPORTED THAT TESTING REVEALED THAT THE BATTERIES OPERATED FOR ONLY ABOUT 25 MINUTES AFTER BEING RECHARGED FOR OVER 8 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD7000 PATIENT MONITOR DSI DRAEGER MEDICAL SYSTEMS, INC. 5202994 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NO