BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVITA

    MDR report key: 445417 · Received February 28, 2003

    Report

    Report Number
    2517967-2003-00028
    Event Type
    Death
    Date Received
    February 28, 2003
    Date of Event
    January 29, 2003
    Report Date
    February 28, 2003
    Manufacturer
    DRAGER MEDICAL AG & CO. KGAA
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PT BECAME DISCONNECTED AT THE AIR WAS SWIVEL ADAPTER ON THE BREATHING CIRCUIT. CPR WAS PERFORMED ON THE PT; HOWEVER, THE PT DIED DUE TO RESPIRATORY AND THEN CARDIAC ARREST. PT EXPIRED IN 2003 AT 4:15 IN THE AFTER NOON. THE DEVICE WAS A RENTAL UNIT. THE VENTILATOR WAS RETURNED TO HOSPITAL. THE VENTILATOR WAS QUARANTINED. A BIOMED, REPORTED THAT A DEVICE CHECK WAS PERFORMED AND THE DEVICE FUNCTIONED NORMALLY. A REVIEW OF THE EVENT LOG INDICATED THAT THE VENTILATOR POSTED APPROPRIATE AUDIBLE ALARMS AND VISUAL MESSAGES AT THE TIME OF THE REPORTED OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA CONTINUOUS VENTILATOR BSZ DRAGER MEDICAL AG & CO. KGAA 4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death