BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE MONITOR B650

    MDR report key: 2820889 · Received October 30, 2012

    Report

    Report Number
    MW5027427
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 30, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER POSITIONING PT LATERAL NON-INVASIVE BLOOD PRESSURE-NIBP-STOPPED CYCLING. UNABLE TO USE MANUAL OR AUTO ICONS ON MONITOR; GRAYISH IN COLOR/FROZEN. ABLE TO ACCESS NIBP MODULE SCREEN BUT ALL ICONS WERE FROZEN. AFTER REBOOTING ALL ICONS FOR NIBP IT FROZE AGAIN. AFTER APPROXIMATELY 10 MINUTES, THE STAFF WAS ABLE TO GENERATE BLOOD PRESSURE AFTER MANUAL ICON BECAME UNFROZEN IN NIBP MODULE SCREEN AND SELF CONVERTED TO AUTO MODE. NO ADVERSE OUTCOMES TO PATIENT. NUMBER: (B)(4) -GE HEALTHCARE-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESCAPE MONITOR B650 BEDSIDE PHYSIOLOGIC MONITOR DSI GE HEALTHCARE CARESCAPE MODEL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other