BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2142718 · Received June 17, 2011

    Report

    Report Number
    3023750-2011-00058
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A DISPLAY THAT WAS NOT WORKING AT ALL. IT IS ATTACHED TO THE ICU1 ACUITY CENTRAL MONITORING SYSTEM. THIS RESULTED IN A TEMPORARY INABILITY TO MONITOR PATIENTS CENTRALLY UNTIL THE CUSTOMER REPLACED THE MONITOR. THERE WAS NO REPORT OF ANY PATIENT HARM AS A RESULT OF THE REPORTED EVENTS. 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 SW 7.10.01

    Patients

    Seq Age Sex Outcome Treatment
    1