BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRAL STATION COMPUTER

    MDR report key: 1766570 · Received June 18, 2010

    Report

    Report Number
    1766570
    Event Type
    Death
    Date Received
    June 18, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 15, 2010
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ON HEART MONITOR. AT 0210, I NOTICED IT SAID ASYSTOLE ON THE MONITOR SCREEN BUT IT WAS NOT ALARMING. SENT OP DOWN TO CHECK MONITOR ON PT. HE WAS FOUND WITHOUT RESPIRATIONS UNRESPONSIVE NO HEARTBEAT. CODE CALLED. WHEN REVIEWING MONITOR RECORD IT WAS FOUND THAT PT WAS BRADY AT 22 STARTING AT 0148 BECAME ASYSTOLE AT 0156 BUT NOBODY NOTICED UNTIL 0210. ON (B)(6) 2010 02:14 PM (B)(6), STAFF ON UNIT DID NOT KNOW THAT THE ALARM COULD BE TURNED OFF, NOR DID BIOMED. MANUFACTURER CONTACTED AND STATED THAT THE NEWER SOFTWARE DOES NOT ALLOW ALARMS TO BE TURNED OFF. SOFTWARE TO BE INSTALLED ASAP. ISSUE: THE UNIT HAS THE ABILITY TO TURN OFF PT ALARMS ON AN INDIVIDUAL ROOM BASIS. THE PT'S WAVEFORMS WILL STILL APPEAR ON THE SCREEN AT THE CENTRAL STATION BUT IN THE EVENT OF A CRISIS ALARM THE UNIT WILL NOT INFORM THE STAFF WITH AN AUDIBLE ALERT. TO TURN OFF THE ALERT IS A SIMPLE STEP AVAILABLE TO ALL STAFF MEMBERS AND NO WARNING OF POSSIBLE INJURY COULD OCCUR WHEN SELECTING THE ALARMS TO OFF. PROBLEM IS CORRECTED WITH SOFTWARE UPGRADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL STATION COMPUTER GENERAL HOSPITAL PRODUCTS MHX GE MEDICAL SYSTEMS CIC VERSION 4.1

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death