BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2904785 · Received December 5, 2012

    Report

    Report Number
    3023750-2012-00103
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR ACUITY SYSTEM'S CPU UNEXPECTEDLY REBOOTED MULTIPLE TIMES. THIS RESULTED IN A TEMPORARY INABILITY TO CENTRALLY MONITOR PATIENTS; HOWEVER, BEDSIDE MONITORING WAS NOT AFFECTED. THERE WAS NO REPORT OF ANY PT HAEM AS A RESULT OF THE REPORTED EVENTS. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1