BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECAREMANAGER V3.6

    MDR report key: 1567316 · Received December 14, 2009

    Report

    Report Number
    1125873-2009-00003
    Event Type
    Malfunction
    Date Received
    December 14, 2009
    Report Date
    December 11, 2009
    Manufacturer
    VISICU
    Product Code
    MSX
    PMA / PMN Number
    K001972
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE NOTE WAS CORRECTLY VOIDED/CANCELLED IN ECAREMANAGER, THE ORIGINAL NOTE IN E-CHART WAS NOT VOIDED/CANCELLED AS EXPECTED. THE NOTE IS CANCELLED IN THE ECAREMANAGER, BUT STILL ACTIVE IN THE CUSTOMER'S E-CHART SYSTEM BECAUSE IT CANNOT FIND THE PARENT RECORD. A DEFECT IN THE ECAREMANAGER SW WAS FOUND TO BE THE CAUSE OF THIS PROBLEM. THE CUSTOMER WAS ADVISED TO DELAY ACTIVATING THE E-CHART INTERFACE UNTIL UPDATED SW WAS AVAILABLE. THE INTERFACE IS NOT IN CLINICAL USE AT ANY CUSTOMER SITE. AS SUCH, THERE IS NO PATIENT RISK ASSOCIATED WITH THIS DEFECT. PHILIPS VISICU CONTROLS THE ACTIVATION OF THIS INTERFACE AND HAS, AT THIS TIME, BLOCKED ANY ACTIVATION. ADDITIONAL INFO: K012171.

    Description of Event or Problem · 1

    DURING INSTALLATION AND TESTING AN INTERFACE BETWEEN ECAREMANAGER AND A THIRD-PARTY E-CHART APPLICATION, THE CUSTOMER REPORTED THAT THE THIRD-PARTY E-CHART APPLICATION DISPLAYED AN ERROR AFTER RECEIVING A 'VOID/CANCEL NOTE' MESSAGE FROM ECAREMANAGER. THE PRODUCT WAS NOT YET IN CLINICAL USE.

    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