BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DASH 4000

    MDR report key: 1082201 · Received July 22, 2008

    Report

    Report Number
    1082201
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 22, 2008
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MOTHER WITNESSED MONITOR GO BLANK AND CALLED RN. ALL OF THE RN'S IN ROOM VERIFIED THAT CIC CENTRAL STATION (INSTALLED AS BACK-UP ALARM SYSTEM) DID NOT ALARM AND WAS ALSO BLANK. MONITOR WAS ABLE TO BE RESTARTED BY SHUTTING THE POWER OFF AND TURNING IT BACK ON AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH 4000 MONITOR, PHYSIOLOGICAL MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DASH 4000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *