BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2152884 · Received June 28, 2011

    Report

    Report Number
    3023750-2011-00062
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K022453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT ONE OF THEIR CPUS ON THE ACUITY CENTRAL MONITORING SYSTEM SHUT ITSELF OFF FOR UNKNOWN REASON. THIS RESULTED IN A TEMPORARY LOSS OF CENTRALIZED MONITORING, HOWEVER, BEDSIDE 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 6.31.01

    Patients

    Seq Age Sex Outcome Treatment
    1