BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVITA 4

    MDR report key: 1622466 · Received March 4, 2010

    Report

    Report Number
    9611500-2010-00010
    Event Type
    Death
    Date Received
    March 4, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 19, 2010
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    CBK
    PMA / PMN Number
    K961687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION ABOUT THE SET UP AND USE OF THE DEVICE DURING THE EVENT, RESULTS OF FURTHER TESTS AFTER THE EVENT HAVE BEEN REQUESTED FOR INVESTIGATION. THE FIRST ANALYSIS OF THE AVAILABLE DEVICE LOG FILE IDENTIFIED SEVERAL ALARM ENTRIES ON THE DATE OF THE EVENT. INVESTIGATION OF THE EVENT IS ON-GOING; RESULTS WILL BE REPORTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR EVITA 4 WITH (B) (4) WHILE USED ON A PATIENT SUDDENLY STOPPED CYCLING. IT WAS FURTHER REPORTED THAT NO ALARM WAS NOTIFIED. ACCORDING TO THE DOCTORS AND NURSES WHO WERE USING THE VENTILATOR, THIS FAIL CAUSED THE DEATH OF ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA 4 CONTINUOUS VENTILATOR CBK DRAEGER MEDICAL AG & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death