BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAGER

    MDR report key: 2518147 · Received April 2, 2012

    Report

    Report Number
    2518147
    Event Type
    Other
    Date Received
    April 2, 2012
    Date of Event
    March 29, 2012
    Report Date
    March 30, 2012
    Manufacturer
    DRAEGER ANESTHESIA
    Product Code
    BSZ
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA MACHINE ARZN-0047 FAILED TO DELIVER MORE THAN 20ML'S OF TIDAL VOLUME UNDER VOLUME CONTROL SETTING AFTER A PT WAS INDUCED UNDER VOLUME CONTROL SETTING AFTER A PT WAS INDUCED UNDER GENERAL ANESTHESIA. THE MACHINE WOULD NOT ALLOW ME TO INCREASE THE TIDAL VOLUME AT ALL. AFTER SWITCHING TO MANUAL/PRESSURE SUPPORT/A DN FINALLY PRESSURE CONTROL, THE MACHINE DID OPERATE IN THE PRESSURE CONTROL SETTING. AFTER OPERATING IN THE PRESSURE CONTROL SETTING FOR APPROX. 30-40 SECONDS I AGAIN ATTEMPTED TO SWITCH TO VOLUME CONTROL WHICH THEN APPEARED TO FUNCTION PROPERLY. THE MACHINE WAS TAKEN OUT OF SERVICE AND DRAGER ANESTHESIA WAS NOTIFIED OF THE EVENT. NO PT HARM OCCURRED. SECOND OCCURRENCE AFTER MACHINE WAS REPAIRED PREVIOUS DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER ANESTHESIA MACHINE BSZ DRAEGER ANESTHESIA FABIUS GS PREMIUM

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR