BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2143613 · Received June 3, 2011

    Report

    Report Number
    3023750-2011-00046
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A BLANK SCREEN ON THEIR ACUITY CENTRAL MONITORING SYSTEM. WELCH ALLYN TECHNICAL SUPPORT WALKED THE CUSTOMER THROUGH TROUBLESHOOTING AND VERIFIED THAT ACUITY WAS UP AND MONITORING PTS, BUT THE DISPLAY SEEMED TO BE INOPERABLE. THIS RESULTED IN A TEMPORARY INABILITY TO MONITOR PTS CENTRALLY UNTIL THE CUSTOMER REPLACED THE MONITOR. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS. THE CUSTOMER DID NOT PROVIDE ANY PT INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1