BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DASH PORT II

    MDR report key: 1932688 · Received December 14, 2010

    Report

    Report Number
    MW5018603
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    GENERAL ELECTRIC
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE DOCKING STATION FOR THE DASH SERIES OF MONITORS FROM GE WILL INTERMITTENTLY DROP OFF THE PT CARE NETWORK. THIS PROBLEM LEAVES THE PT UNMONITORED AT A CENTRAL LOCATION. NO ALARMS REPORTING CAN OCCUR. GE'S FIX IS TO ROUTINELY CLEAN THE MONITOR CONTACTS THAT CONNECT TO THE DOCKING STATION. I FEEL THIS IS A POOR DESIGN, A POOR SOLUTION TO THE PROBLEM, AND THIS DESIGN IS A PT SAFETY ISSUE. GE ONLY SENT A LETTER TO THOSE THAT WERE COMPLAINING ABOUT THE PROBLEM. I FELT THE LETTER SHOULD HAVE ALERTED EVERYONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH PORT II DOCKING STATION MHX GENERAL ELECTRIC DASH PORT II

    Patients

    Seq Age Sex Outcome Treatment
    1 Other