BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2251178 · Received August 10, 2011

    Report

    Report Number
    3023750-2011-00075
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 FINISHED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT CPU OF HIS ACUITY CENTRALIZED PT MONITORING SYSTEM UNEXPECTEDLY SHUTDOWN THREE (3) TIMES. THIS RESULTED IN A TEMPORARY LOSS OF CENTRALIZED PT MONITORING. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENT. 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 7.02.00

    Patients

    Seq Age Sex Outcome Treatment
    1