BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA 4

    MDR report key: 1883255 · Received October 14, 2010

    Report

    Report Number
    9611500-2010-00041
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 14, 2010
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K961687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING. RESULTS WILL BE REPORTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR STOPPED WORKING WHILE BEING USED ON PT. NO ALARMS WERE GENERATED. A RESTART WAS POSSIBLE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA 4 CONTINUOUS VENTILATOR CBK DRAGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK