BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DASH 3000, 4000 , 5000, REV 7.3

    MDR report key: 4173115 · Received October 13, 2014

    Report

    Report Number
    4173115
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    August 1, 2013
    Report Date
    October 13, 2014
    Manufacturer
    GE HEALTHCARE, LLC
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    CLINICIANS HAVE NOTED THAT THEY HAVE WITNESSED CONTINUOUS REBOOTING OF THE DASH MONITORS. DURING OUR INVESTIGATION IT WAS NOTED THAT THE NURSES HAVE REPORTED THIS PROBLEM DURING A PATIENT'S ADMISSION OR DISCHARGE OR WHEN THEY ARE RESTARTING THE MONITOR. THERE HAVE BEEN SEVERAL REPORTS IN THE FALL OF 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647328 DASH 3000, 4000 , 5000, REV 7.3 PHYSIOLOIGCAL MONITOR MHX GE HEALTHCARE, LLC DASH *

    Patients

    Seq Age Sex Outcome Treatment
    1 *