BEUDAMED
    FDA Adverse Event Summary report: N

    CARESCAPE B650

    MDR report key: 3979478 · Received July 16, 2014

    Report

    Report Number
    3979478
    Date Received
    July 16, 2014
    Date of Event
    April 29, 2014
    Report Date
    July 16, 2014
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN RECOVERY BAY 7 CONNECTED TO A GE CARESCAPE B650. ACCORDING TO THE NURSE, THE MONITOR TURNED ITSELF OFF AND THEN BACK ON. NO INJURY WAS REPORTED FROM THE INCIDENT.====================== MANUFACTURER RESPONSE FOR MONITOR, MULTI PARAMETER, CARESCAPE B650 (PER SITE REPORTER)======================WE HAD CONTACTED OUR GE REPRESENTATIVE AND WERE INFORMED GE IS WORKING ON PROVIDING AN SOLUTION TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416131 CARESCAPE B650 MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION O MHX GE HEALTHCARE CARESCAPE B 650 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *