BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGUS SYSTEM

    MDR report key: 4733240 · Received April 24, 2015

    Report

    Report Number
    1125873-2015-00010
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Report Date
    March 24, 2015
    Manufacturer
    VISICU
    Product Code
    MSX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REMOTE CONNECTIVITY WILL BE USED TO EVALUATE THE SOFTWARE AT THE HEALTH SYSTEM. THE MANUFACTURER IS CURRENTLY INVESTIGATING THE ISSUE AND A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    VISICU RECEIVED A REPORT FROM A HEALTH SYSTEM STATING THAT ECAREMANAGER AUTOMATED ACUITY AND DISCHARGE READINESS SCORE INFORMATION IS NOT UPDATING FOR A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273369 ARGUS SYSTEM ECAREMANAGER 3.9 MSX VISICU 865325

    Patients

    Seq Age Sex Outcome Treatment
    1