BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECARECOORDINATOR

    MDR report key: 6350719 · Received February 22, 2017

    Report

    Report Number
    1125873-2017-00004
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Report Date
    February 20, 2017
    Manufacturer
    VISICU, INC - DUP
    Product Code
    DRG
    PMA / PMN Number
    K141706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS Q AND R HAS COMPLETED THE INVESTIGATION FOR THIS FAILURE. PHILIPS RECEIVED A FIX FOR THIS ISSUE AND THE FIX WAS APPLIED TO ECARE COORDINATOR PRODUCTION AND SANDBOX (TEST) ENVIRONMENTS SOMETIME BETWEEN THURSDAY MAY 4, 2017 AND FRIDAY MAY 5, 2017. Q&R WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    A SALESFORCE SOFTWARE DEFECT WAS DISCOVERED THAT PREVENTS DATA TRANSACTIONS FROM BEING ROLLED BACK WHEN THERE IS AN EXCEPTION ERROR. THIS CAN CAUSE PARTIAL DATA TO BE SAVED WHENEVER AN EXCEPTION OCCURS IN THE PHILIPS ECARECOORDINATOR (ECC) CLINICAL USER INTERFACE. SPECIFIC AREAS OF CONCERN ARE THE CLINICAL NOTES AND PATIENT CALENDAR FEATURES OF ECC. ALTHOUGH NO HARM HAS BEEN CAUSED BY THIS DEFECT, IT HAS THE POTENTIAL TO RESULT IN HARMFUL SCENARIOS IF CLINICAL COMMUNICATIONS TO PATIENTS ARE NOT SAVED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133751 ECARECOORDINATOR ECARECOORDINATOR DRG VISICU, INC - DUP 453564506091

    Patients

    Seq Age Sex Outcome Treatment
    1