BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL STATION

    MDR report key: 1051183 · Received May 22, 2008

    Report

    Report Number
    3023750-2008-00131
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MHX
    PMA / PMN Number
    K972121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CPU (CENTRAL PROCESSING UNIT) OF THE ACUITY CENTRAL STATION PATIENT MONITORING SYSTEM COULD NOT BE SUCCESSFULLY POWERED ON. THERE WERE NO PATIENTS CONNECTED TO THE SYSTEM AT THE TIME THE PROBLEM WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL STATION MHX WELCH ALLYN PROTOCOL, INC. ACUITY SW 4.03.06 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1