BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2902920 · Received November 29, 2012

    Report

    Report Number
    3023750-2012-00097
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONFIRMED THAT THE DISPLAY FAILED. THE SONY DISPLAY IS AN OFF-THE-SHELF COMPUTER PERIPHERAL MADE BY ANOTHER MFR AND SOLD BY WELCH ALLYN. WELCH ALLYN DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUBCOMPONENTS AS THE SOURCE OF THE FAILURE. METHOD - CUSTOMER CONFIRMED DISPLAY FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR SONY DISPLAY IS SHUTTING OFF AFTER RUNNING FOR A FEW MINUTES. CUSTOMER REPLACED DISPLAY WITH SPARE. NO PRODUCT IS BEING RETURNED. THERE WAS NO REPORT OF ANY PT HARM 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. DISPLAY, 19", ANA

    Patients

    Seq Age Sex Outcome Treatment
    1