BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERSON

    MDR report key: 555685 · Received April 28, 2004

    Report

    Report Number
    1216146-2004-00001
    Event Type
    Malfunction
    Date Received
    April 28, 2004
    Date of Event
    February 22, 2004
    Report Date
    April 8, 2004
    Manufacturer
    J.H. EMERSON CO.
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EMERSON PUMP FAILURE. HAD BEEN WORKING 10 MINUTES EARLIER. POWER LIGHT ON, GAUGE AT 0 WITH DIAL TURNED TO MEDIUM BETWEEN MINIMUM AND MAXIMUM. NO NOISE OR VIBRATION FROM MACHINE. PT HAD INCREASED SUBCUTANEOUS AIR AND SP02 DECREASED TO LO 90'S. SWITCHED PUMP AND PT O2 INCREASED IMMEDIATELY. PUMP DETERMINED TO BE AT END OF LIFE AND NOT REPAIRABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERSON ASPIRATOR/SUCTION KDQ J.H. EMERSON CO. 55-JS *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R