BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE MONITOR B650

    MDR report key: 3192157 · Received June 20, 2013

    Report

    Report Number
    9610105-2013-00011
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    MHX
    PMA / PMN Number
    K102239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT DATA NOT CURRENTLY AVAILABLE. INVESTIGATION WAS ABLE TO REPRODUCE THE REPORTED ISSUE: STEPS TO REPRODUCE: MONITOR IS PUT TO STANDBY. REMOTE DISCHARGE IS DONE ON THE MONITOR WHILE IT IS IN STANDBY. AFTER THESE STEPS, ALARMS ARE NO LONGER BROADCASTED TO THE UNITY NETWORK. THE SITUATION IS ONLY RECOVERED BY REBOOTING THE MONITOR, OR RETURNING TO STANDBY AND ENDING IT BY SOME OTHER WAY THAN REMOTE DISCHARGE. THERE IS NO PROBLEM WHEN USING THE S5 NETWORK. THE ALARM NETWORK INTERFACE DOES NOT SEND ALARMS TO THE NETWORK WHEN IT THINKS THE MONITOR IT IS STANDBY. THE SOFTWARE ERROR WILL BE CORRECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE B650 MONITOR WITH 2.0.1 SOFTWARE DISCHARGED A PT FROM THE MONITOR REMOTELY FROM A CLINICAL INFO CENTER (CIC) CENTRAL STATION WHILE THE MONITOR WAS ON STANDBY STATE. AFTER A NEW PT WAS ADMITTED IN THE SAME B650 MONITOR, THE ALARMS WERE NOT BROADCASTED TO THE CIC. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281126 CARESCAPE MONITOR B650 MULTI-PARAMETER PATIENT MONITOR MHX GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1