BEUDAMED
    FDA Adverse Event Death Summary report: N

    FABIUS GS

    MDR report key: 1253323 · Received December 9, 2008

    Report

    Report Number
    9611500-2008-00042
    Event Type
    Death
    Date Received
    December 9, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 19, 2008
    Manufacturer
    DRAGER MEDICAL AG & CO. KG
    Product Code
    BSZ
    PMA / PMN Number
    K011404
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MACHINE WAS TESTED BY THE LOCAL BIOMED WHO REPORTED THAT IT PASSED ALL TESTS, AND WAS RETURNED TO USE. THE ANESTHESIOLOGIST AND DIRECTOR OF THE SICU (SURGICAL ICU) STATED THAT HE DID NOT BELIEVE AT THIS TIME THAT ANY MACHINE MALFUNCTION WAS PRESENTED OR CONTRIBUTED TO THE NEGATIVE PATIENT OUTCOME. THE INVESTIGATION OF THE MANUFACTURER IS ONGOING. THE RESULTS WILL BE REPORTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE DOCTOR WAS HAVING DIFFICULTY OXYGENATING THE PATIENT AND NOTICED THAT THE VENTILATOR WAS NOT RUNNING. IT WAS REPORTED THAT THE RED ALARM LEDS WERE NOT LIT AND THE MACHINE WAS NOT ALARMING. IT WAS REPORTED THAT THE DOCTOR WAS ABLE TO ACTIVATE MAN/SPONT MODE BY PRESSING THE MAN/SPONT MODE KEY AND WAS ALSO ABLE TO ACTIVATE THE VOLUME MODE BY PRESSING THE VOLUME MODE KEY. THE CASE WAS COMPLETED USING THIS MACHINE. IT WAS REPORTED THAT THE PATIENT DID NOT REGAIN CONSCIOUSNESS AND EXPIRED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FABIUS GS ANAESTHESIA WORKSTATION BSZ DRAGER MEDICAL AG & CO. KG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death