BEUDAMED
    FDA Adverse Event Death Summary report: N

    DATEX-ENGSTROM LIGHT MONITOR

    MDR report key: 1673183 · Received April 29, 2010

    Report

    Report Number
    9610105-2010-00006
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 29, 2010
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    DRT
    PMA / PMN Number
    K981378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE RECEIVED THE SYSTEM (LIGHT MONITOR, SPO2 FINGER SENSOR, AND POWER ADAPTER) FOR INVESTIGATION. THE SYSTEM WAS TESTED AND WAS FOUND TO OPERATE AS DESIGNED. THE MONITOR LOGS WERE INVESTIGATED, BUT THERE WERE NO ENTRIES IN THE TIME OF INCIDENT 2010-(B) (6). THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE IS THAT THE ALARM WAS SILENCED TWICE (INSTEAD OF ONCE) WHEN A PULSE WAS NOT DETECTED. IN THIS CASE, THE MONITOR WILL NOT TRIGGER A NEW ALARM FOR THE SAME ISSUE. THE LIGHT MONITOR USER'S REFERENCE MANUAL CONTAINS THE FOLLOWING INFO: SILENCING ALARMS: WARNING: PT SAFETY: DO NOT TURN OFF AUDIBLE ALARMS WITHOUT ASSUMING CONTINUOUS, DIRECT OBSERVATION OF THE PT. SILENCING ALARMS ALSO DISABLES THE EXTERNAL NURSE CALL SIGNAL. SILENCING ALARMS FOR TWO MINUTES: PRESS SILENCE ALARMS. THE SYMBOL WITH A COUNTDOWN TIMER APPEARS ON THE SCREEN, AND THE MESSAGE IS CLEARED FROM THE DISPLAY. MESSAGES OF NEW ALARMS ALSO APPEAR DURING SILENCING PERIOD. AFTER TWO MINUTES, ALL SILENCED ALARMS AND NURSE CALL FUNCTION WILL RETURN TO NORMAL ALARM OPERATION. REACTIVATE ALARMS: PRESS THE SILENCE ALARMS KEY DURING THE SILENCING PERIOD. THE ALARM SOUNDS OF NEW ALARMS AND THE NURSE CALL SIGNAL ARE ACTIVATED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PT DEATH OCCURRED, AND THE CAREGIVERS DID NOT HEAR SPO2 ALARMS. ECG (ELECTROCARDIOGRAM) WAS REPORTEDLY NOT CONNECTED. THE EVENT WAS DISCOVERED WHEN AN EMPLOYEE "PASSING BY NOTED THAT (THE) PT WAS PALE." A LOCAL TECHNICIAN EXAMINED THE MONITOR AFTER THE EVENT. THE MONITOR HAD BEEN RESTARTED, AND THEREFORE DID NOT INCLUDE TRENDS OR ALARM HISTORY. A SYSTEM CHECK WAS COMPLETED, AND NO ERRORS WERE NOTED. ALL ALARM FUNCTIONS WERE TESTED AND DETERMINED TO BE WORKING CORRECTLY. THE MONITOR WAS DISMANTLED, AND THE LOUDSPEAKER WAS TESTED. NO ERRORS WERE NOTED. THE SPO2 CABLE AND PROBE WERE TESTED AS WELL, WITH NO NOTED ERRORS. IT SHOULD BE NOTED THAT THE MONITOR INVOLVED IN THE REPORTED EVENT IS OVER NINE YEARS OLD, AND IS SERVICED BY HOSPITAL TECHNICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-ENGSTROM LIGHT MONITOR CARDIAC MONITOR DRT GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1 Death