BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVITA XL

    MDR report key: 1002991 · Received February 8, 2008

    Report

    Report Number
    9611500-2008-00007
    Event Type
    Other
    Date Received
    February 8, 2008
    Date of Event
    January 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    CBK
    PMA / PMN Number
    K980642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING TRANSPORT OF A PT - VENTILATED BY AN EVITAXL, THE RIGHT REAR WHEEL CASTER OF THE TROLLEY FELL OFF, THE DEVICE TIPPED OVER AND FELL ONTO A HOSP EMPLOYEE. THE EMPLOYEE WAS ADMITTED INTO THE ED, TREATED AND PLACE ON MEDICAL LEAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA XL CONTINOUS VERNTILATOR CBK DRAEGER MEDICAL AG & CO. KG * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other