BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPONENT MONITORING SYSTEM

    MDR report key: 307998 · Received December 8, 2000

    Report

    Report Number
    1218950-2000-00239
    Event Type
    Injury
    Date Received
    December 8, 2000
    Date of Event
    October 29, 2000
    Report Date
    November 14, 2000
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE PT WAS ADMITTED TO ER WITH GI BLEED AND WAS ALSO SUFFERING FROM RENAL FAILURE. PT WAS TRANSFERRED TO SICU AND PUT ON HEMODIALYSIS. PT WAS PUT ON RESTRAINTS, BUT WAS FOUND LYING ON THE FLOOR BLEEDING FROM CENTRAL PRESSURE LINE. LOST APPROX. 300ML OF BLOOD. PT WAS FOUND ON FLOOR IN ASYTOLE. NURSES CLAIM THEY DIDN'T HEAR ALARMS GOING OFF, AND WHEN BIOMED WAS CALLED, THEY FOUND THE ALARM SUSPEND BUTTON WAS INDEFINITE. BIOMED CHANGED INDEFINITE SUSPEND TO 2 MINUTE SUSPEND. PATIENT IS CURRENTLY DEPENDENT ON VENTILATOR, AND PERMANENT BRAIN DAMAGE IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPONENT MONITORING SYSTEM CMS DRT AGILENT TECHNOLOGIES, INC. M1176A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L