BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA, MODEL UNKNOWN

    MDR report key: 3802866 · Received April 30, 2014

    Report

    Report Number
    9611500-2014-00034
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 30, 2014
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K961687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DRAGER TRIED TO GET MORE DETAILED INFORMATION, BUT WITHOUT SUCCESS. IT COULD NOT BE CLARIFIED WHICH DEVICE WAS IN USE DURING THE EVENT. PROBABLY IT WAS A DEVICE OF EVITA FAMILY. AS THE CONCERNED DEVICE WAS NOT IDENTIFIED, NO DEVICE LOG WAS AVAILABLE FOR INVESTIGATION. THE CONCERNED CO2-CUVETTE WAS ALSO NOT MADE AVAILABLE. DUE TO THIS MISSING INFORMATION ONLY A GENERAL STATEMENT CAN BE GIVEN. TH ECOR-CUVETTE IS PLACED BETWEEN Y-PIECE AND ENDOTRACHEAL TUBE. AT THIS POSITION IT IS POSSIBLE TO DISTINGUISH THE VALUES FOR INSPIRATION AND EXPIRATION. IF THE CUVETTE DISCONNECTS AS REPORTED, THE COMPLETE HOSE SYSTEM IS DISCONNECTED FORM THE PATIENT. THIS WILL RESULT IN ALARMS OF HIGH PRIORITY WITH EACH INTENSIVE CARE VENTILATOR, AS VOLUME AND PRESSURE MONITORING ARE ALWAYS INTEGRATED FUNCTIONS OF THOSE DEVICES. MULTIPLE ALARMS FOR TIDAL VOLUME, PRESSURE, LEAKAGE AND CO2-APNOE (IF AVAILABLE) WILL FOLLOW, SEQUENCE DEPENDING ON MEASUREMENT RESULTS AND ALARM SETTINGS OF USERS. DEVICE RELATED INVESTIGATION WAS NOT POSSIBLE. NO DEVICE MALFUNCTION WAS REPORTED. THE REPORTED EVENT IS AN ISOLATED CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CO2-CUVETTE DISCONNECTED DURING VENTILATION. CLINICAL CONSEQUENCE REPORTED: DESATURATION, BRADYCARDIA 57, EXTERNAL CARDIAC MASSAGE FOR 4 MINUTES + ADRENALINE, HEMODYNAMIC UNSTABLE, UNFAVORABLE EVOLUTION, DEATH OF THE PATIENT 6 HOURS AFTER INCIDENT. DEATH WAS EXPECTED DUE TO PATIENTS BAD STATE OF HEALTH AND NOT ATTRIBUTED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258234 EVITA, MODEL UNKNOWN VENTILATOR, CRITICAL CARE CBK DRAEGER MEDICAL GMBH UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention