BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVITA 4

    MDR report key: 251887 · Received November 24, 1999

    Report

    Report Number
    1217183-1999-00001
    Event Type
    Death
    Date Received
    November 24, 1999
    Date of Event
    October 27, 1999
    Report Date
    November 23, 1999
    Manufacturer
    DRAGER MEDIZINTECHNIK GAMBH
    Product Code
    GKP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE AN INSTRUMENTATION LABORATORY FIELD SERVICE ENGINEER WAS SERVICING AN ELECTRA 1800C COAGULATION ANALYZER AT A CUSTOMER SITE, THE UPPER SAMPLE SHIELD DOOR FELL AND CUT THE TOP OF HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA 4 VENTILATOR, CONTINUOUS GKP DRAGER MEDIZINTECHNIK GAMBH 1800C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death