BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3063155 · Received February 27, 2013

    Report

    Report Number
    3023750-2013-00020
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 30, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K120774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    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

    BASED ON THE INVESTIGATION OF MDR 3023750-2013-00003 WELCH ALLYN TECHNICAL SUPPORT DISCOVERED THAT THE SYSTEM REBOOTED ITSELF. THIS OCCURRED AT: (B)(6). 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 EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84547 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY 8.20.00

    Patients

    Seq Age Sex Outcome Treatment
    1