BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL STATION

    MDR report key: 1051211 · Received May 23, 2008

    Report

    Report Number
    3023750-2008-00134
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K022453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET ARRIVED FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS UNABLE TO SUCCESSFULLY POWER-UP A LAPTOP COMPUTER USED TO RUN THE ACUITY CENTRAL PT MONITORING SYSTEM SOFTWARE. THE REPORTER STATED THAT THE LAST TIME THEY USED THE DEVICE IT WAS CONNECTED TO UNDERPOWERED AND/OR DIRTY POWER. THE CUSTOMER WAS IN THE PROCESS OF GETTING READY TO CONNECT THE DEVICE TO A PT WHEN THE PRODUCT PROBLEM WAS DISCOVERED. NO PT WAS ACTUALLY CONNECTED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL STATION DSI WELCH ALLYN PROTOCOL, INC. ACUITY SW 6.31.01 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1