BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2503282 · Received March 21, 2012

    Report

    Report Number
    3023750-2012-00020
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 INDICATED THAT THEIR ACUITY SYSTEM HAD A WHITE SCREEN ERROR, CAUSING THE SYSTEM TO BE UNRESPONSIVE. A RESTART WAS PERFORMED TO BRING THE SYSTEM BACK ON-LINE. THE CUSTOMER DID NOT PROVIDE ANY PT INFO; THERE WERE NO PTS ATTACHED TO THE SYSTEM AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI DSI WELCH ALLYN PROTOCOL, INC. ACUITY S/W 6.40.01

    Patients

    Seq Age Sex Outcome Treatment
    1