BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3150275 · Received May 29, 2013

    Report

    Report Number
    3023750-2013-00055
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 REQUESTED REMOTE ASSISTANCE TO RESET SYSTEM TIME. DURING THE TIME CHANGE ASSISTANCE, WELCH ALLYN TECH SUPPORT NOTED THAT THE ACUITY SYSTEM REBOOTED UNEXPECTEDLY. THIS RESULTED IN A TEMPORARY INABILITY TO CENTRALLY MONITOR PTS, HOWEVER BEDSIDE MONITORING WAS NOT AFFECTED. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS. THE CUSTOMER DID NOT PROVIDE ANY PT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233750 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY 8.10.00

    Patients

    Seq Age Sex Outcome Treatment
    1