BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVINA

    MDR report key: 3170405 · Received June 7, 2013

    Report

    Report Number
    9611500-2013-00036
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 4, 2013
    Report Date
    June 5, 2013
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K003068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOS AND THE DEVICE LOG WERE INVESTIGATED BY THE MFR. THE ANALYSIS OF THE DESCRIPTION, THE PHOTOS AND THE DEVICE LOG SHOWED THAT DURING VENTILATION WITH 100% OXYGEN AN IGNITION OUTSIDE THE DEVICE (PT HOSE SYSTEM) OCCURRED, WHICH AFFECTED THE OUTER PART OF THE VENTILATOR. NO DEVICE MALFUNCTION CAUSED THE REPORTED PROBLEM. THE USER ALSO INDICATED NO DEVICE MALFUNCTION. THE INSTRUCTIONS FOR USE (IFU) CONTAIN A WARNING REGARDING THE USE OF ELECTRO-SURGICAL EQUIPMENT DURING VENTILATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS CONNECTED TO THE RESPIRATOR SAVINA (TRACHEOTOMY) AND VENTILATED WITH THE MIXTURE OF 50%, DURING A SURGICAL DIATHERMY TREATMENT AN INFLAMMATION OF OXYGEN OCCURRED. THE PT SUFFERED BURNS. THE VENTILATOR WAS BURNED. ACCORDING TO THE HEAD OF THE EQUIPMENT DEPARTMENT THE INCIDENT WAS CAUSED BY THE FAULTY USE OF DIATHERMY BY THE HOSPITAL STAFF (DIATHERMY USED WITH THE RESPIRATOR ON).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253406 SAVINA RESPIRATOR INTENSIVE CARE CBK DRAEGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening