BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2022196 · Received March 11, 2011

    Report

    Report Number
    3023750-2011-00020
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 6, 2011
    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 DEVICE EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS FINISHED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HIS ACUITY CENTRALIZED PATIENT MONITORING SYSTEM WAS AT A SCREEN PROMPTING "PRESS CTRL-D OR GIVE ROOT PASSWORD FOR MAINTENANCE." W/A TECHNICAL SUPPORT WALKED THE CUSTOMER THROUGH RUNNING A FSCK -Y COMMAND AND THIS WAS SHOWING NUMEROUS ERRORS THAT APPEAR TO BE A HARD DISK FAILURE. THIS RESULTED IN A LOSS OF CENTRALIZED MONITORING, HOWEVER, BEDSIDE MONITORING WAS NOT AFFECTED. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENT. NOTE 1 FOR BLOCK A: 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. ACUITY SW 6.40.01

    Patients

    Seq Age Sex Outcome Treatment
    1