BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA 4

    MDR report key: 2220137 · Received August 4, 2011

    Report

    Report Number
    9611500-2011-00026
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 2, 2011
    Report Date
    August 3, 2011
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K961687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION AT THE MFR, IT WAS NOT POSSIBLE TO REPRODUCE THE REPORTED BEHAVIOR. FOR THE REPORTED TIME OF EVENT THE DEVICE LOG SHOWS A SWITCH OFF OF THE DEVICE WHICH TOOK NOT PLACE ACCORDING TO THE USER'S REPORT. DUE THE DEVICE LOG ANALYSIS AND THE HEPATICS OF THE MAINS SWITCH DURING INVESTIGATION IT WAS CONCLUDED THAT THE MAINS SWITCH WAS THE ROOT CAUSE FOR THE EVENT. MECHANICAL WEAR INSIDE THE SWITCH PROVOKED THE SWITCH TO CHATTER WHICH LEAD TO A SWITCH OFF OF THE DEVICE. THE SWITCHING STATUS OF THE SWITCH IS DETECTED BY TWO INDEPENDENT MECHANISMS. THE INVOLVED DEVICE IS INTENDED FOR SPECIAL OXYGEN THERAPY IN A HYPERBARIC PRESSURE CHAMBER (EVITA 4 HBO). DURING THIS THERAPY THE REGULAR MAINS SUPPLY OF THE DEVICE IS NOT USED, THEREFORE ONE OF THE TWO MECHANISMS FOR SWITCHING STATUS DETECTION COULD NOT BE USED. IF A MECHANICAL PROBLEM EXISTS IN THE SECOND MECHANISM A COMPLETE SHUT OFF CAN NOT BE EXCLUDED. IN THE INSTRUCTIONS FOR USE OF THE EVITA 4 HBO IT IS MENTIONED THAT THE DEVICE SHOULD BE USED UNDER SURVEILLANCE OF QUALIFIED MEDICAL STAFF, TO BE ABLE TO REACH IN CASE OF A MALFUNCTION. GLOBALLY, THERE EXISTS ONLY ON ADD'L EVITA 4 HBO IN (B)(6). THE MAINS POWER SWITCH OF THIS SECOND DEVICE WILL BE ALSO CHANGED AS A PREVENTIVE MEASURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING VENTILATION IN A HYPERBARIC PRESSURE CHAMBER THE VENTILATOR STOPPED VENTILATION AND EMITTED ONLY A SHORT ACOUSTICAL SIGNAL. NO PT INJURY HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK