BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3810211 · Received February 5, 2014

    Report

    Report Number
    3023750-2014-00003
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S IT STAFF DETERMINED THAT THE ROOT CAUSE OF THE SHUTDOWN WAS AN OVERHEATED CPU POWER SUPPLY SWITCHING OFF. THE SITE TECHNICIAN REMOVED THE CPU COVER AND REMOVED/VACUUMED THE DUST CONTAMINATION. ONCE THIS MAINTENANCE WAS COMPLETE, THE CPU REBOOT AND PERFORMED AS DESIGNED. THE UNIT WILL NOT BE RETURNED. THIS INCIDENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION. CPU POWER SUPPLIES ARE OFF-THE-SHELF SUB-COMPONENTS MADE BY ANOTHER MANUFACTURER AND SOLD BY WELCH ALLYN, WELCH ALLYN DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUB-COMPONENTS AS THE SOURCE OF FAILURE. METHOD: OTHER (CUSTOMER TECHNICIAN VISUALLY CONFIRMED THAT MAINTENANCE WAS NEEDED).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR ACUITY WOULD NOT REBOOT AFTER UNEXPECTED SHUT DOWN. WELCH ALLYN TECH SUPPORT ASSISTED THE CUSTOMER IN TROUBLESHOOTING, BUT THE CUSTOMER WAS UNABLE TO GET IT FULLY RESTARTED. 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 EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75765 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ULTRA 45

    Patients

    Seq Age Sex Outcome Treatment
    1