BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2449734 · Received February 8, 2012

    Report

    Report Number
    3023750-2012-00008
    Event Type
    Malfunction
    Date Received
    February 8, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 20, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 STATED THAT THEIR ACUITY PT MONITORING SYSTEM REBOOTED RESULTING IN THE TEMPORARY LOSS OF CENTRALIZED PT MONITORING. THIS EVENT DID NOT RESULT IN ANY PT HARM. 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 S/W 8.10

    Patients

    Seq Age Sex Outcome Treatment
    1