BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA 2 DURA

    MDR report key: 2473100 · Received February 16, 2012

    Report

    Report Number
    2473100
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    February 11, 2012
    Report Date
    February 16, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER HEARD THE APNEA ALARM SOUNDING FROM OUTSIDE THE PATIENT ROOM. UPON INSPECTION, THE RESPIRATION AND MINUTE VENTILATION WERE ZERO. THE PATIENT REPORTED THEY WERE ABLE TO BREATHE. APPROXIMATELY ONE MINUTE PASSED BEFORE ANY NUMBERS REGISTERED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA 2 DURA VENTILATOR CBK DRAEGER MEDICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES