BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA

    MDR report key: 5103149 · Received September 25, 2015

    Report

    Report Number
    1220063-2015-00024
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    September 15, 2015
    Report Date
    October 26, 2015
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K070566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICS CLINICAL AND DIAGNOSTIC LOG FILES AS WELL AS THE BEDSIDE DELTA MONITOR MAIN DIAGNOSTIC AND FRONTEND DIAGNOSTIC LOG FILES WERE REVIEWED TO ASSIST IN THE ROOT CAUSE DETERMINATION OF THE REPORTED ISSUE. THERE WERE NO MAIN OR FRONTEND SOFTWARE ERRORS LOGGED DURING THE LOW SPO2 EVENT, AN INDICATION THAT THE SOFTWARE WAS FUNCTIONING NORMALLY. AS THE BEDSIDE MONITOR ALARM HISTORY LOGS WERE OVERWRITTEN IT CANNOT BE CONCLUSIVELY DETERMINED IF THE ALARM EVENT WAS LOGGED AT THE BEDSIDE MONITOR. HOWEVER, THE ALARM LIMIT CONFIGURATION WAS PROVIDED FOR SPO2 AND VERIFY THAT ALARMS WERE ENABLED WITH UPPER LIMIT N=100 AND LOWER LIMIT N=86 THEREFORE IT IS EXPECTED THAT THE DEVICE WILL ALARM IF THE CONFIGURED LIMITS ARE BREACHED. IT IS DETERMINED THAT THE CENTRAL STATION RECEIVED THE INFORMATION FROM THE BEDSIDE MONITOR AND THERE WAS INDICATION IN THE ICS CLINICAL LOG THAT THE MONITOR ALERTED THE USER AT THE ICS AT 11:22PM AND WAS SILENCED PRIOR TO THE REPORTED INCIDENT OCCURRENCE AT 11:50PM AND THEN SILENCED AGAIN AT 11:54PM AFTER THE INCIDENT. FIELD SERVICE ENGINEER PROVIDED THE INFORMATION THAT THE ICS AND DELTA WERE CHECKED AND NO PROBLEM WAS FOUND WITH THE ALARM. THE ALARMS WORKED AS INTENDED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED BUT IS NOT YET CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN THE FOLLOW UP-REPORT.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2015 AROUND 11H50 PM A PATIENT HAS BEEN DISCOVERED WITH A VERY LOW SPO2 AND AP. AFTER THIS EVENT PATIENT HAS BEEN REANIMATED AND INTUBATED. TO THIS DATE, THE PROGNOSIS FOR SURVIVAL OF THE PATIENT IS COMMITTED. AFTER REVIEW "ICS EVENTS" WE CAN CONFIRM THAT ALARM WAS STORED. WE WERE NOT ABLE TO SEE THESE ALARMS ON DELTA BECAUSE THEY WERE DELETED BY SYSTEM (MAXIMUM EVENTS ON DELTA). CUSTOMER ASKS IF DELTA/ICS RANG DURING THIS PROBLEM. ICS AND DELTA WAS REVIEWED BY FSE AND NO PROBLEM WAS FOUND (SPEAKER / BUZZER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636735 DELTA PHYSIOLOGICAL MONITORING SYSTEMS CBK DRAEGER MEDICAL SYSTEMS, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening