BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2192596 · Received July 1, 2011

    Report

    Report Number
    3023750-2011-00065
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL IS NOT YET COMPLETE. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER AT THE FACILITY INDICATED THAT NURSING STAFF REPORTED THAT THEY HAVE BEEN EXPERIENCING AN ISSUE WHERE A PT "DROP OFF" THE SYSTEM. NO NOTICES, NO TELEMETRY ERRORS, NO DROPOUT MESSAGES, THE PT TILE WINDOW SIMPLY DISAPPEAR. THIS RESULTED IN A TEMPORARY LOSS OF CENTRALIZED MONITORING, HOWEVER, BESIDES MONITORING WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY S/W 7.01.00

    Patients

    Seq Age Sex Outcome Treatment
    1