BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2982831 · Received January 31, 2013

    Report

    Report Number
    3023750-2013-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K120774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 CUSTOMER REPORTED THAT THEIR ACUITY LOOKED LIKE IT HAD REBOOTED AND WAS FROZEN. TECH SERVICE DIALED INTO THE SYSTEM AND FOUND THAT THE PRIMARY CPU HAD LOCKED UP DURING A REBOOT AND NEVER RESTARTED. THE SECONDARY CPU THEN REBOOTED, RESULTING IN A LOSS OF CENTRALIZED MONITORING FOR APPROXIMATELY 1 MINUTE, 49 SECONDS. THE PRIMARY CPU WAS ABLE TO BE RECOVERED BY CYCLING POWER. THIS RESULTED IN A TEMPORARY INABILITY TO CENTRALLY MONITOR PTS, HOWEVER BEDSIDE MONITORING WAS NOT AFFECTED. THERE WAS NO REPORT OF 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
    41926 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY 8.20.00

    Patients

    Seq Age Sex Outcome Treatment
    1