BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2901862 · Received November 21, 2012

    Report

    Report Number
    3023750-2012-00099
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR ED1 ACUITY CPU REBOOTED ITSELF WITH CORE FILES. WELCH ALLYN TECHNICAL SUPPORTED DOWNLOADED LOG FILES FOR EVAL. 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. 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 8.10.01

    Patients

    Seq Age Sex Outcome Treatment
    1