BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 998987 · Received January 31, 2008

    Report

    Report Number
    998987
    Event Type
    Death
    Date Received
    January 31, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 31, 2008
    Manufacturer
    ALLIED HEALTH CARE PRODUCTS, INC.
    Product Code
    JCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WITH A HISTORY OF ALCOHOL ABUSE AND LIVER DISEASE CODED. THE HEART RHYTHM WAS ASYSTOLE AND CPR WAS ADMINISTERED IMMEDIATELY. PATIENT VOMITED COPIUS AMOUNT OF FLUID AND THE SUCTION REGULATOR FROM THE CRASH CART HAD TO BE USED. THE UNIT WORKED AT FIRST, HOWEVER WHEN THE NURSE ATTEMPTED TO INCREASE THE INTENSITY CONTROL, THE INTERNAL SHAFT ON THE REGULATOR BROKE. THE DOCTOR WAS UNABLE TO SEE THE AIRWAY TO INTUBATE THE PATIENT. STAFF WAS UNABLE TO REVIVE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * REGULATOR, WALL SUCTION JCX ALLIED HEALTH CARE PRODUCTS, INC. 22-13-1105 0699 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death