BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2031739 · Received February 25, 2011

    Report

    Report Number
    3023750-2011-00015
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT WHEN HE BROUGHT HIS ACUITY CENTRALIZED PATIENT MONITORING SYSTEM DOWN TO REPLACE THE KEYBOARD, THE SYSTEM BOOTED TO "CANNOT OPEN" /ETC/PATH_TO_INST." MESSAGE. A BOOT -R COMMAND DID NOT RESOLVE THE PROBLEM. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THE REPORTED EVENT. THE CUSTOMER DID NOT PROVIDE ANY PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY SW 6.31.00

    Patients

    Seq Age Sex Outcome Treatment
    1