BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA

    MDR report key: 2446082 · Received January 29, 2012

    Report

    Report Number
    2446082
    Event Type
    Malfunction
    Date Received
    January 29, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 24, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE VENT ALARMED DEVICE FAILURE AND SYSTEM REBOOT. THERE WAS AN APPARENT INTERNAL COMMUNICATION FAILURE ACCORDING TO OP MANUAL FOR "DEVICE FAILURE (3)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA VENTILATOR CBK DRAEGER MEDICAL GMBH V500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR