BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3061497 · Received March 27, 2013

    Report

    Report Number
    3023750-2013-00040
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K120774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    A REVIEW OF LOG FILES BY THE DISTRIBUTOR ON (B)(6) 2013 INDICATED THAT THE CUSTOMER'S ACUITY SYSTEM'S CPU UNEXPECTEDLY REBOOTED. THIS RESULTED IN A TEMPORARY INABILITY TO CENTRALLY MONITOR PTS, HOWEVER BESIDE MONITORING WAS NOT AFFECTING. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS. (B)(4): THE CUSTOMER DID NOT PROVIDE ANY PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125163 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY 8.20.00

    Patients

    Seq Age Sex Outcome Treatment
    1