BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROMETRICS

    MDR report key: 297738 · Received September 22, 2000

    Report

    Report Number
    MW1020004
    Event Type
    Malfunction
    Date Received
    September 22, 2000
    Report Date
    September 22, 2000
    Manufacturer
    GE MEDICAL SYSTEMS/MARQUETTE
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/13/00: IN PERFORMING A RISK ASSESSMENT, IT WAS DETERMINED THAT, IN ORDER, FOR DATA TO BE SENT TO THE WRONG BED, THREE SIMULTANEOUS EVENTS MUST OCCUR -(1) THE MONITORS MUST BE ON A COROLAN NETWORK; (2) ADDRESS CHECKING IN THE MONITORS / WALLPLATES IS NOT TURNED ON; AND (3) A HARDWARE FAILURE IN THE COROLAN OR THE CABLES MUST OCCUR. SINCE THE LIKELIHOOD OF ALL THREE EVENTS OCCURRING SIMULTANEOUSLY IS SMALL, THE PROBABILITY OF OCCURRENCE IS NEGLIGIBLE. AS DISCUSSED ABOVE, THE HOSP QS SYSTEM HAS BEEN INSTALLED FOR OVER 5 YEARS AND PREVIOUSLY HAD NOT REPORTED PROBLEMS OF THIS NATURE. IT IS LIKELY THAT STRESSES WERE PLACED ON THE CABLES OR MONITORS, CAUSING A HARDWARE FAILURE (OPEN ADDRESS LINES). MFR'S INFO TECHNOLOGIES' SVC WENT TO THE FACILITY TO VERIFY THAT THE MONITORS, CABLES, WALLPLATES, ETC. WERE WORKING PROPERLY WHILE THE MONITOR AND COROLAN NETWORK CONTINUED TO BE USED AT HOSP. NO PROBLEMS WERE FOUND. IN RESPONSE TO THE CUSTOMER REQUEST, SVC HAS COMPLETED THE PROCESS OF REPLACING THE COROLAN NETWORK WITH A SERIAL MONITORING NETWORK.

    Description of Event or Problem · 1

    DATA FROM THE FETAL MONITORS IS BEING INCORRECTLY PLACED IN THE ELECTRONIC CHARTING SYSTEM. DATA IS BEING TRANSPOSED FROM ONE PT TO ANOTHER - E.G., BED #1 DATA MAY BE INCORRECTLY ASSIGNED TO BED #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROMETRICS FETAL MONITOR KXN GE MEDICAL SYSTEMS/MARQUETTE COROMETRICS 118 *
    2 QMI ELECTRONIC CHARTING DSF GE MEDICAL SYSTEMS/MARQUETTE QMI *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other