BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 15778 · Received July 18, 1994

    Report

    Report Number
    15778
    Event Type
    Injury
    Date Received
    July 18, 1994
    Date of Event
    January 26, 1994
    Report Date
    February 1, 1994
    Manufacturer
    BAXTER EDWARDS
    Product Code
    DXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LOW CARDIAC OUTPUT PROMPTED NURSING STAFF TO ABANDON CONTINUOUS CARDIAC OUTPUT MONITORING TO MANUAL INJECTATE PROBE WHICH GAVE HIGHER OUTPUT. AFTER SEVERAL HOURS OF USE, THE NURSING STAFF RESUMED USE WITH ANOTHER CONTINUOUS CARDIAC OUTPUT MONITOR. THE READINGS WITH THE MANUAL PROBE WERE HIGHER THAN READINGS FROM BOTH CONTINUOUS MONITORING PROBES. THIS RESULTED IN A DELAY OF ADMINISTRATION OF PRESSOR DRUGS. CONCURRENTLY WITH THIS EVENT, PATIENT SUFFERED A MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CARDIAC OUTPUT UNJECTATE PROBE DXG BAXTER EDWARDS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 * Hospitalization