BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECAREMANAGER V3.6

    MDR report key: 1504045 · Received September 21, 2009

    Report

    Report Number
    1125873-2009-00002
    Event Type
    Malfunction
    Date Received
    September 21, 2009
    Report Date
    April 28, 2009
    Manufacturer
    VISICU
    Product Code
    MSX
    PMA / PMN Number
    K001972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K) # K012171. ECAREMANAGER IS A SW PROGRAM THAT ALLOWS CLINICIANS THAT ARE NOT IN THE LOCAL CLINICAL AREA TO SUPPORT THE CARE OF ICU PTS. ALL MEDICATIONS THAT HAVE BEEN ORDERED SINCE A PT WAS ADMITTED ARE SHOWN ON THEIR CURRENT MEDICATION LIST. IF A MEDICATION IS NOT INCLUDED ON THE LIST, THIS COULD PREVENT ACCURATE DIAGNOSIS OR LEAD TO DUPLICATE OR INAPPROPRIATE MEDICATION ORDERS. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT, AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INTERFACED MEDICATION INFO SENT FROM THE HOSP INFO SYSTEM FROM THE TIME THE PT IS DELETED FROM ECAREMANAGER TO THE TIME, THEY ARE RE-ESTABLISHED IN ECAREMANAGER IS OMITTED FROM THEIR CURRENT MEDICATION LIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECAREMANAGER V3.6 ECAREMANAGER MSX VISICU

    Patients

    Seq Age Sex Outcome Treatment
    1