BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA

    MDR report key: 2980151 · Received February 19, 2013

    Report

    Report Number
    9611500-2013-00015
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 4, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K970165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE VENTILATORS' LOG FILE REVEALED THAT THE DEVICE HAS SWITCHED OVER TO EXTERNAL BATTERY FOR THE TIME OF THE POWER OUTAGE WITHOUT IMPACT TO VENTILATION. THIS IS SUBSTANTIATED BY THE FACT THAT THE USER HIMSELF COULD NOT DUPLICATE THE PROBLEM. REPORTEDLY, A SIMULATION OF POWER SUPPLY FAILURE RESULTED IN THE FINDING THAT THE VENTILATOR RESPONDED AS INTENDED BY SWITCHING TO BATTERY SUPPLY. FURTHERMORE, THERE'S NO LOG ENTRY OF A TECHNICAL ISSUE WHICH WOULD CAUSE A TEMPORARY DARK DISPLAY. BUT INDEED, A LARGE LEAKAGE WAS PRESENT INTO AIRWAY SYSTEM FOR THE WHOLE DAY OF EVENT WHICH HAD SIGNIFICANT IMPACT ON THE VENTILATION. SOMETIMES, THIS LEAKAGE WAS EVEN EXCEEDING THE VENTILATORS' CAPABILITY FOR COMPENSATION AND, TOO LOW FLOW WAS MEASURED AT THE OUTPUT. THE DEVICE SWITCHED OVER TO APNEA VENTILATION, CONSEQUENTLY. CORRESPONDING ALARMS WERE EXECUTED AND EVIDENTIALLY SILENCED BY THE OPERATOR. THESE LEAKAGE-CAUSED FLOW LIMITATIONS AT THE INTERFACE TO THE PT MAY HAVE BEEN MISINTERPRETED BY THE USER AS AN INTERRUPT IN VENTILATION. IN ANY CASE, THE NECESSITY TO SWITCH OVER TO MANUAL VENTILATION WAS NOT CAUSED BY AN ASSUMED INADEQUATE DEVICE RESPONSE TO THE MAINS SUPPLY FAILURE. NO PT CONSEQUENCES HAVE OCCURRED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72865 EVITA CRITICAL CARE VENTILATOR CBK DRAEGER MEDICAL GMBH 2 DURA NA

    Patients

    Seq Age Sex Outcome Treatment
    1