BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIMUS

    MDR report key: 2980799 · Received February 22, 2013

    Report

    Report Number
    9611500-2013-00011
    Event Type
    Death
    Date Received
    February 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 12, 2013
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED PRIMUS WAS TESTED ACCORDING TO DRAEGER SPECIFICATION. THE ELECTRONIC LOG FILE WHICH CONSISTS OF A USER LOG AND A DEVICE LOG WAS AVAILABLE FOR INVESTIGATION. DUE TO ACTIVITIES AFTER THE REPORTED EVENT A PART OF THE RELEVANT USER LOG SECTION HAD ALREADY BEEN OVERWRITTEN SO THAT USER DATA WAS NOT AVAILABLE FOR THE REPORTED TIME OF THE EVENT. HENCE, IT WAS NOT POSSIBLE TO RECONSTRUCT THE COURSE OF EVENTS EXACTLY. BASED ON THE DEVICE LOG ENTRIES THERE WAS NO TECHNICAL FAILURE. THE VENTILATOR PROVIDED THE SET VOLUME AND BASED ON THE LOGGED INSPIRATORY OXYGEN CONCENTRATION (90%) SUFFICIENT FRESH GAS WAS AVAILABLE. THE DEVICE DETECTED A COMBINED FLOW AND PRESSURE APNEA WHICH RESULTED FROM A SIGNIFICANT CIRCUIT LEAK CAUSED BY TEMPORARY DISCONNECTION OF THE PT. IN THIS CASE THE PRIMUS WILL GENERATE CORRESPONDING VISIBLE AND AUDIBLE ALARMS. THE PRIMUS WAS TESTED ACCORDING TO DRAEGER SPECIFICATION WITHOUT DEVIATION. ESPECIALLY THE ALARM FUNCTIONS OPERATED AS SPECIFIED. NO DEVICE FAILURE COULD BE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED: THE PT WAS NOT RECEIVING OXYGEN. PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78384 PRIMUS ANESTHESAIA VENTILATOR BSZ DRAEGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death