BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DASH 500 MONITORS

    MDR report key: 3143192 · Received May 29, 2013

    Report

    Report Number
    3143192
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 24, 2013
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DASH 5000 MONITORS UNABLE TO: PROVIDE CONTINUOUS CARDIAC TELEMETRY MONITORING, UNABLE TO PERFORM A 12 EKG. THIS HAS BEEN AN INTERMITTENT ISSUE WITH THE MONITORS SINCE PURCHASE AND INSTALLMENT IN OUR FACILITY IN (B)(6) 2012. OUR FACILITY DID NOT HAVE ANY DASH 5000 MONITORS WITH PRODUCT CODE SHQ. IN (B)(6) 2012 THE COMPANY REPLACED SOME MONITOR MODULES AND OUR FACILITY CONTINUED TO HAVE INTERMITTENT ISSUES WITH EKG FUNCTION OF THE MONITORS. PER OUR FACILITY CLINICAL ENGINEERING DEPARTMENT, THEY CONTACTED THE COMPANY DURING THE WEEK OF (B)(6) 2013 HAD REQUESTED IF THE COMPANY WOULD BE ABLE TO TELL US WHETHER THE COMPANY HAD INADVERTENTLY PLACED SHQ CODE PRODUCTS IN OUR MONITORS LAST (B)(6) (2012) BECAUSE WE HAVE CONTINUED TO EXPERIENCE ISSUES WITH THE MONITORS. NO RESPONSE HAS BEEN REC'D AS OF THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237532 DASH 500 MONITORS NONE MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other