BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA

    MDR report key: 5099774 · Received September 24, 2015

    Report

    Report Number
    1220063-2015-00027
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    September 11, 2015
    Report Date
    October 27, 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
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE ERROR LOG FILES OF THE INFINITY DELTA MONITOR AND THE CORRESPONDING INFINITY CENTRAL STATION WERE PROVIDED FOR THE INVESTIGATION. ALARM HISTORY LOGS WERE NOT PROVIDED AS THE USER REPORTED THEY WERE NOT AVAILABLE DUE TO THE LATE NOTIFICATION AFTER THE EVENT. ADDITIONALLY, SCREENSHOTS FROM THE VENTILATOR, BEDSIDE MONITOR, AND ICS WERE SUPPLIED TO ASSIST IN A ROOT CAUSE DETERMINATION. FROM THE TREND DATA IT WAS VERIFIED THAT THE PATIENT EXPERIENCED A SIGNIFICANT DECREASE IN VITAL PARAMETER BETWEEN 16:35 AND 16:45 ON (B)(6). THE DELTA ERROR LOG CONTAINED NO ENTRY INDICATING A PRODUCT MALFUNCTION ON THE REPORTED DAY OF EVENT. THE LOG ENTRIES FROM THE CENTRAL STATION REVEALED THAT THE USER PAUSED THE ALARMS FOR THE AFFECTED BED 14 AT THE CENTRAL STATION DURING THE REPORTED TIME FRAME. FURTHERMORE THE CENTRAL STATION WAS ALERTED BY THE BEDSIDE MONITOR THAT THE MEASUREMENT FOR SPO2 COULD NOT BE DETERMINED AND ISSUED A (***) TO ALERT THE USER. THE DELTA IFU STATES THAT SPO2 MEASUREMENTS ARE PARTICULARLY SENSITIVE TO THE PULSATIONS IN THE ARTERY AND THE ARTERIOLE AND MAY NOT BE ACCURATE IF THE PATIENT IS EXPERIENCING SHOCK, HYPOTHERMIA, ANEMIA OR HAS RECEIVED CERTAIN MEDICATIONS THAT REDUCE THE BLOOD FLOW IN THE ARTERIES. THE SCREEN SHOT OF THE VENTILATOR ALARM LOG SHOWED THAT SEVERAL "AIRWAY PRESSURE LOW" AND "TIDAL VOLUME HIGH" WERE GENERATED IN THE REPORTED TIME FRAME. THE BEDSIDE MONITOR WAS FUNCTIONALLY AND TECHNICALLY TESTED AND NO MALFUNCTION WAS DETECTED. ALARM FUNCTIONALITY WORKED AS EXPECTED ALERTING THE USER VIA ALARMS AT THE MONITOR AND THE ICS. AFTER THE EVENT THE MONITOR WAS PUT BACK INTO USE WITHOUT REOCCURRENCE. THE ROOT CAUSE FOR THE MISSING ALARMS COULD NOT BE CONCLUSIVELY DETERMINED. LOG FILES AND THE TECHNICAL ANALYSIS SHOWED NO MALFUNCTION OF THE MONITOR. THE LOG ENTRIES OF THE CENTRAL STATION INDICATE THAT THE ALARM PAUSE BUTTON FOR THE AFFECTED BED 14 WAS PRESSED. ADDITIONALLY, THE ALARM LOG OF THE VENTILATOR SHOWS THAT SEVERAL VENTILATION ALARMS WERE GENERATED.

    Description of Event or Problem · 1

    THE PATIENT INCIDENT WAS REPORTED NOT BEFORE (B)(4) 2015 AT 19:45 VIA THE EMERGENCY HOTLINE BY THE NURSE OUSTABSIDS. THE PATIENT IN BED 14 HAD ON (B)(6) 2015 AT ABOUT 16:45 A MASSIVE DECREASE OF THE VITAL PARAMETERS BY UNEXPLAINABLE REASONS. THE PATIENT REPORTEDLY RECOVERED. THE PERSONAL WAS BUSY AT THE TIME WITH ADMISSION OF 2 NEW PATIENTS. THE MONITOR REPORTEDLY HAS NOT GIVEN ANY ALARM. THEREFORE STAFF DID NOT RECOGNIZE THE INCIDENT. BECAUSE THE DESAT -ALARM WAS TURNED ON AT THE MONITOR WITH -20, THE MONITOR SHOULD HAVE TRIGGERED A LIMIT VALUE ALARM FOR SAO2-MONITORING AND AFTERWARDS A LIFE-THREATENING ALARM. FOR THE HEART RATE AND PRESSURE MONITORING A LIMIT ALARM HAD TO BE TRIGGERED. DUE TO THE LATE NOTIFICATION THIS COULD NOT BE FOUND IN THE ALARM REPORT OF THE MONITOR. A FUNCTIONAL CHECK AND ALARM TRANSMISSION TO THE ICS SHOWED NO MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633531 DELTA PHYSIOLOGICAL MONITORING SYSTEMS CBK DRAEGER MEDICAL SYSTEMS, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1