BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVITA

    MDR report key: 2425093 · Received January 18, 2012

    Report

    Report Number
    2517967-2012-00003
    Event Type
    Death
    Date Received
    January 18, 2012
    Date of Event
    December 30, 2011
    Report Date
    January 3, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT DIED WHILE CONNECTED TO THE VENTILATOR. THE STAFF WAS NOT ALLEGED THAT THE VENTILATOR CAUSED OR CONTRIBUTED TO THE DEATH OF THE PT. FURTHER DISCUSSIONS WITH THE CUSTOMER CONFIRMED THAT AT THE TIME OF THE REPORTED INCIDENT, ALTHOUGH THE PT WAS CONNECTED TO THE VENTILATOR, THE VENTILATOR WAS NOT TURNED ON. THE HOSPITAL ALSO REPORTED THAT A REVIEW OF THE DEVICE LOGS FROM A THIRD PARTY MONITOR SHOWED THAT THE THIRD PARTY MONITOR ALARMED FOR APNEA 13 TIMES BUT WAS SILENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA VENTILATOR, CONTINUOUS CBK DRAEGER MEDICAL GMBH 2 DURA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death