BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3063355 · Received March 28, 2013

    Report

    Report Number
    3023750-2013-00041
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    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 ALLEGED THAT THE ACUITY WAVEFORMS WERE FROZEN AND THAT IT SAID "TYPE GO TO RESUME". ONCE "GO" WAS TYPED, THE SYSTEM REBOOTED SUCCESSFULLY. THIS RESULTED IN A TEMPORARY INABILITY TO CENTRALLY MONITOR PTS, HOWEVER, BESIDE MONITORING WAS NOT AFFECTED. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS. NOTE 1 FOR BLOCK A: THE CUSTOMER DID NOT PROVIDE ANY PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127468 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY 7.10.00

    Patients

    Seq Age Sex Outcome Treatment
    1