BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECAREMANAGER

    MDR report key: 1815104 · Received August 14, 2010

    Report

    Report Number
    1125873-2010-00003
    Event Type
    Other
    Date Received
    August 14, 2010
    Report Date
    August 13, 2010
    Manufacturer
    PHILIPS VISICU
    Product Code
    MSX
    PMA / PMN Number
    K012171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A SPECIFIC, UNEXPECTED WORKFLOW, ECAREMANAGER USERS WHO HAVE ESTABLISHED A REMOTE AUDIO/VISUAL LINK INTO A PT ROOM WILL NOT SEE ON THEIR COMPUTER SCREEN AN ICON INDICATING THAT THEIR MICROPHONE HAS BEEN MUTED. THIS MAY IMPEDE A CLINICIAN'S COMMUNICATIONS WITH THE PT OR BEDSIDE CAREGIVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECAREMANAGER CLINICAL DECISION-SUPPORT SOFTWARE MSX PHILIPS VISICU V3.7.1

    Patients

    Seq Age Sex Outcome Treatment
    1