BEUDAMED
    FDA Adverse Event Death Summary report: N

    S-SCORT TEN

    MDR report key: 244762 · Received October 13, 1999

    Report

    Report Number
    2022724-1999-00003
    Event Type
    Death
    Date Received
    October 13, 1999
    Date of Event
    September 9, 1999
    Report Date
    October 12, 1999
    Manufacturer
    SSCOR, INC.
    Product Code
    JCX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEPTEMBER 15, 1999 SSCOR RECEIVED A REPORT FROM REPORTER OF A FIRE DEPT WHICH INFORMED SSCOR THAT ON SEPTEMBER 9, 1999 A FIRE DEPT ANSWERED A CALL THAT A CHILD WAS CHOKING. WHEN THE PARAMEDICS ARRIVED AT THE SCENE THEY FOUND A 22 MONTH OLD CHILD CHOKING ON A PENCIL. THE FIRE DEPT'S PARAMEDICS REMOVED THE PENCIL AND DETERMINED THAT IT WAS NECESSARY TO PERFORM CPR. THE CHILD'S AIRWAY WAS FILLED WITH FLUID AND THE PARAMEDICS USED A S-SCORT TEN SUCTION UNIT. THE SUCTION UNIT WAS MANUFACTURED BY SSCOR ON 10/09/1996 AND WAS SOLD WITH A BATTERY MANUFACTURED BY PANASONIC. AFTER INITIALLY CLEARING THE AIRWAY, THE PARAMEDICS PUT THE SUCTION UNIT ASIDE WITH THE MOTOR STILL RUNNING. THE PARAMEDICS WENT TO PERFORM CPR, BUT THE AIRWAY FILLED UP WITH FLUID AGAIN. THE PARAMEDICS GRABBED THE SAME SUCTION UNIT IN AN ATTEMPT TO REMOVE THE FLUID. THE PARAMEDICS DETERMINED THERE WAS NOT SUFFICIENT SUCTION TO REMOVE THE FLUID BECAUSE THE BATTERY WAS LOSING POWER. AT THIS POINT, THE PARAMEDICS CHOSE NOT TO USE THE ALTERNATE METHOD OF SUCTION AVAILABLE, A HAND HELD V-VAC DEVICE, BUT INSTEAD, CHOSE TO TAKE THE CHILD AND THE S-SCORT SUCTION UNIT BACK TO THEIR VEHICLE. THE INFANT AND SUCTION UNIT WERE MOVED TO THE VEHICLE AND THE SUCTION UNIT WAS PUT BACK IN THE CHARGING/RETENTION SHELF THAT WAS INSTALLED IN THE VEHICLE WHERE IT USED THE VEHICLE BATTERY TO POWER THE MOTOR. THE UNIT FUNCTIONED TO REMOVE THE FLUID FROM THE CHILD'S AIRWAY AND THE PARAMEDICS WERE ABLE TO INTUBATE THEIR PT. SEPTEMBER 24, 1999 REPORTER OF THE FIRE DEPT CALLED SSCOR TO REPORT THE PT HAD PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-SCORT TEN BATTERY POWERED PORTABLE ASPIRATOR JCX SSCOR, INC. 2100S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Death