BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2466836 · Received February 17, 2012

    Report

    Report Number
    3023750-2012-00010
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 STATED THAT THEY WERE NOT ABLE TO GET ANY WIRELESS CONNECTIONS WITH ACUITY. WELCH ALLYN TECH SERVICE VERIFIED THAT ALL OF THEIR ACCESS POINTS (APS) WERE REPORTING DOWN. REBOOTED THE CONTROLLER - ALL OF THE APS SUBSEQUENTLY REBOOTED A FEW TIMES AND THEN WENT BACK DOWN. A TEMPORARY WORK AROUND WAS PUT IN PLACE TO ESTABLISH COMMUNICATIONS. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. THE CUSTOMER DID NOT PROVIDE ANY PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY S/W 7.10.01

    Patients

    Seq Age Sex Outcome Treatment
    1