BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGUS SYSTEM

    MDR report key: 4619137 · Received March 17, 2015

    Report

    Report Number
    1125873-2015-00007
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Report Date
    February 20, 2015
    Manufacturer
    VISICU
    Product Code
    MSX
    PMA / PMN Number
    K001972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 COMPLETED.

    Description of Event or Problem · 1

    VISICU RECEIVED A REPORT FROM A HEALTH SYSTEM STATING THAT ECAREMANAGER AUTOMATED ACUITY ICON IS NOT UPDATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179739 ARGUS SYSTEM ECAREMANAGER 3.9 MSX VISICU 865325

    Patients

    Seq Age Sex Outcome Treatment
    1