BEUDAMED
    FDA Adverse Event Death Summary report: N

    DATEX-OHMEDA S/5 CRITICAL CARE MONITOR

    MDR report key: 1877352 · Received October 13, 2010

    Report

    Report Number
    9610105-2010-00018
    Event Type
    Death
    Date Received
    October 13, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GE HEALTHCARE FINLAND
    Product Code
    DSI
    PMA / PMN Number
    K021376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS UNK. THE DEVICE WAS SHIPPED ON 06/15/2007. GE HEALTHCARE'S INVESTIGATION INCLUDED AN ON-SITE EVAL AS WELL AS A REVIEW OF THE ICENTRAL (CENTRAL STATION) ECG PRINTOUTS AND LOG FILES. THE MFG SITE DID NOT RECEIVE THE S/5 CCM MONITOR OR PSM MODULE FOR INVESTIGATION. A GE FIELD SERVICE ENGINEER (FE) PERFORMED THE ON-SITE EVAL ON SEP 15, 2010. THE MONITOR WAS CHECKED WITH A SIMULATOR AND WAS FOUND TO OPERATE ACCORDING TO SPECS. THE ELECTRODES WERE PLACED ON THE FE TO CHECK THE SIGNAL QUALITY, AND NO PROBLEMS WERE OBSERVED. ENGINEERING REVIEW OF THE ICENTRAL ECG PRINTOUTS SHOW SEVERAL PERIODS OF ASYSTOLE AND ARRHYTHMIA BEGINNING AT 8:18 AM. ALARMS WERE ACTIVATED AS SPECIFIED. THE ICENTRAL LOG FILES REVEAL THAT CONTINUOUS ASYSTOLE AND ARRHYTHMIA ALARMS WERE OCCURRING FROM 9:00 AM TO 1:11 PM (ESCALATED FROM YELLOW TO RED). THE ALARMS WERE EITHER SILENCED OR ACKNOWLEDGED. ACCORDING TO THE LOGS, THE HEART RATE DROPPED TO 0 (ZERO) AT 1:05:16 PM AND AN ASYSTOLE ALARM WAS ACTIVATED AT 1:05:18 PM, TWO SECONDS LATER. FROM 1:05:18 PM, THE ASYSTOLE ALARM WAS SILENCED FOR 2 MINUTES, FIVE TIMES UNTIL THE ALARM WAS ACKNOWLEDGED AT 1:06:56 PM. ACCORDING TO THE LOGS, THE ASYSTOLE ALARMS WERE ACTIVATED AS SPECIFIED AND NO DELAY IN ALARMING WAS OBSERVED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE ON-SITE INVESTIGATION AND ENGINEERING REVIEW OF THE LOG FILES AND PRINTOUTS INDICATE THE DEVICE PERFORMED ACCORDING TO SPECS.

    Description of Event or Problem · 1

    A NURSE REPORTEDLY CONTACTED THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) AT 9:00 AM STATING THAT THE S/5 CCM MONITOR WAS ACTIVATING FALSE ASYSTOLE ALARMS, SHOWING A HEART RATE OF ZERO (0). UPON ARRIVAL, THE BIOMED NOTED THAT THE PT'S HAIR MAY HAVE BEEN INTERFERING WITH THE SIGNAL AND RECOMMENDED THAT THE NURSE REDO THE SKIN PREPARATION. THE NURSE REPORTEDLY UTILIZED PENETRATION GEL TO IMPROVE THE SIGNAL, AND THE BIOMED REPOSITIONED THE ELECTRODES AND MOVED THE LEAD FROM DII TO DI. THE SIGNAL REPORTEDLY IMPROVED AND HEART RATE WAS 132 WITH A GAIN OF 5. THE BIOMED REPORTEDLY RETURNED TO THE ICU AT APPROX 1:10 PM TO CHECK THE MONITOR, BUT LEARNED AT THIS TIME THAT THE PT HAD EXPIRED. THE PT DEATH REPORTEDLY OCCURRED AT 1:05PM, AND THE S/5 CCM ALLEGEDLY DID NOT PROVIDE AN ASYSTOLE ALARM UNTIL APPROX 10 TO 30 SECONDS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR PATIENT MONITOR DSI GE HEALTHCARE FINLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death VERSION: 5.0.3 MODULE PSM, (B)(4)| ICENTRAL L-NET05, (B)(4)| PART NO. EPSMP00