BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICENTRAL

    MDR report key: 1297585 · Received January 28, 2009

    Report

    Report Number
    9610105-2009-00001
    Event Type
    Death
    Date Received
    January 28, 2009
    Date of Event
    January 19, 2009
    Report Date
    January 28, 2009
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    DRT
    PMA / PMN Number
    K022507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PACER PT WAS IN A ROOM WITH A POSSIBLY CLOSED DOOR. THE PT WAS FOUND EXPIRED AND FALLEN OUT OF BED WITH TWO LEADS OFF. THE HEALTHCARE STAFF ALLEGEDLY DID NOT HEAR AN ALARM ON THE SYSTEM. PER ONSITE EVALUATION BY THE HOSPITAL BIOMED, THE ICENTRAL DID NOT HAVE A DISPLAY WITH INTERNAL SPEAKERS; RATHER IT HAD AN EXTERNAL ACTIVE PC SPEAKER. THE SYSTEM WAS CHECKED AND FOUND TO HAVE PERFORMED AS DESIGNED. IT IS NOTED THAT THE SOUND VOLUME OF THE EXTERNAL SPEAKERS WAS TURNED DOWN TO A VERY LOW AUDIBLE LEVEL AND THE ALARM LEVEL WAS "ISO2" (BEEP EACH ~ 20 SEC). THE USER CONTROLS THE VOLUME ON THE EXTERNAL SPEAKERS. GE DOES NOT PROVIDE EXTERNAL SPEAKERS FOR ICENTRAL SYSTEMS. THE DISPLAY MODEL AT THE CUSTOMER SITE IS NOT DELIVERED FROM GE HEALTHCARE FINLAND. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICENTRAL NETWORKING PRODUCTS DRT GE HEALTHCARE FINLAND OY S-CNET02

    Patients

    Seq Age Sex Outcome Treatment
    1 Death