BEUDAMED
    FDA Adverse Event Other Summary report: N

    JULIAN

    MDR report key: 932759 · Received April 5, 2007

    Report

    Report Number
    9611500-2007-00021
    Event Type
    Other
    Date Received
    April 5, 2007
    Date of Event
    February 7, 2007
    Report Date
    April 5, 2007
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    BSZ
    PMA / PMN Number
    k983635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION AT MFR SITE IS ONGOING. RESULTS WILL BE REPORTED IN A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, WHILE PREPARING THE JULIAN (ANESTHESIA WORKSTATION) FOR A MEDICAL PROCEDURE, THE DEVICE BECAME UNSTABLE AND TIPPED OVER. THE CHASSIS AT THE FRONT RIGHT SIDE WITH THE CASTOR WAS BROKEN. NO FURTHER CONSEQUENCES FOR PT OR USER WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JULIAN ANESTHESIA WORKSTATION BSZ DRAEGER MEDICAL AG & CO. KG * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR