BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECARECOORDINATOR

    MDR report key: 4894283 · Received July 2, 2015

    Report

    Report Number
    1125873-2015-00012
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 6, 2015
    Report Date
    June 6, 2015
    Manufacturer
    VISICU, INC.
    Product Code
    DRG
    PMA / PMN Number
    K141706
    Removal / Correction Number
    1125873-2015-00012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS ISSUE MEETS THE REQUIREMENTS OF A REPORTABLE CORRECTION.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    PHILIPS VISICU RECEIVED A REPORT FROM A HEALTH SYSTEM USER THAT THE OUT OF BOUNDS WEIGHT FLAG DID NOT TRIGGER AS EXPECTED BY THE CLINICAL TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431542 ECARECOORDINATOR ECARECOORDINATOR DRG VISICU, INC. 453564506091

    Patients

    Seq Age Sex Outcome Treatment
    1