BEUDAMED
    FDA Adverse Event Death Summary report: N

    V24/26 COMPONENT MONITORING SYSTEM

    MDR report key: 1071743 · Received July 9, 2008

    Report

    Report Number
    1218950-2008-00390
    Event Type
    Death
    Date Received
    July 9, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 13, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION. A PHILIPS CUSTOMER ENGINEER (CE) TESTED BOTH THE BEDSIDE MONITOR (M1205A) AND CENTRAL STATION (M3150B) USING AN ECG SIMULATOR. BOTH DEVICES PERFORMED TO SPECIFICATIONS, PROVIDING ALARMS AS APPROPRIATE FOR SIMULATED PT CONDITIONS. A REVIEW OF THE LOG DATA FILES FOR BED MONITOR SHOWS THAT HEART RATE ALARMS HAD BEEN TURNED OFF THE DAY BEFORE AT 12:12:57 PM, AND THAT THEY REMAINED OFF THROUGHOUT THE INCIDENT TIMEFRAME. BEDSIDE (M1205A) HEART RATE ALARMS WERE TURNED ON AFTER THE INCIDENT THE NEXT DAY AT 10:32:26 AM. A REVIEW OF THE WAVE AND EVENT REVIEW DATA SHOWS THAT THE BEDSIDE MONITOR RECOGNIZED THE CHANGES AND DETERIORATION IN THE PT'S CONDITION. BUT SINCE THE HEART RATE ALARMS WERE TURNED OFF DURING THE INCIDENT TIMEFRAME, NO ALARMS WERE PROVIDED. A REVIEW OF THE STRIP REPORT PROVIDED SHOWS THAT AT APPROX 09:55 AM THAT DAY, THE PT'S HEART RATE WAS 32 BPM, SPO2 SATURATION LEVEL WAS AT 55%, AND A PVC COUNT OF 4 WAS NOTED. THE STRIPS ALSO SHOW VENTRICULAR, MISSED, AND ARTIFACT BEAT LABELS. THE FACT THAT NO ALARMS WERE PROVIDED FOR THE SPO2 LIMIT VIOLATION / DESAT EVENT IS MOST CONSISTENT WITH SPO2 ALARMS ALSO BEING TURNED OFF DURING THE INCIDENT TIMEFRAME. WHEN ALARMS FOR A MEASURED PARAMETER ARE TURNED OFF, A BELL SYMBOL WITH AN "X" THROUGH IT WILL BE DISPLAYED BESIDE THE PARAMETER. WHEN ARRHYTHMIA ALARMS ARE TURNED OFF AT THE BEDSIDE (EITHER THROUGH THE SELECTION OF PULSE AS THE ALARM SOURCE, OR BY TURNING THE ALARMS OFF), THE DEVICE WILL DISPLAY A BELL WITH AN "X" THROUGH IT NEXT TO THE "HR" PARAMETER. THE INOP MESSAGE "ALL ARRHYTHMIA ALARMS OFF" WILL BE DISPLAYED IN THE UPPER LEFT CORNER OF THE DISPLAY SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IN 2008 FROM 9:53 TO 10:02 DESPITE PROGRESSIVE BRADYCARDIA LEADING TO ASYSTOLE, AN ALARM WAS NOT GENERATED ON THE PT MONITOR AND PIC. IT CAUSED DELAYED RESUSCITATION ACTION OF THE PT. PT CATEGORY WAS SET ON PIC AS "CHILD" (NOT NEONATAL) FOR BABY. AS THE RESULT OF THE DELAYED RESUSCITATION ACTION, THE PT, DESPITE RETURN OF THE SINUS RHYTHM, IS HOSPITALIZED IN ICU. THE EEG PERFORMED AFTER THE INCIDENT DIDN'T SHOW ELECTRIC ACTIVITY OF THE BRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V24/26 COMPONENT MONITORING SYSTEM BEDSIDE MONITOR DRT PHILIPS MEDICAL SYSTEMS M1205A

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Death