BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FABIUS G S ANESTHESIA MACHINE

    MDR report key: 1623550 · Received March 1, 2010

    Report

    Report Number
    MW5014980
    Event Type
    Injury
    Date Received
    March 1, 2010
    Date of Event
    January 20, 2010
    Report Date
    March 1, 2010
    Manufacturer
    DRAEGER MEDICAL, INC
    Product Code
    CAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE HAD A BROKEN FLOWMETER ON A DRAEGER ANESTHESIA MACHINE. THIS RESULTED IN A HUGE LEAK IN THE ANESTHESIA BREATHING CIRCUIT. THE ANESTHETIST WAS UNABLE TO VENTILATE THE PT UNTIL AN AMBU BAG PORTABLE VENTILATOR COULD BE ACQUIRED. THERE WAS NO INJURY TO THE PT, BUT THE POTENTIAL WAS THERE. WE HAVE NOW FOUND OUT THAT DRAEGER KNEW THERE WAS A PROBLEM SEVERAL YEARS AGO, AND PRODUCED A REPAIR. WE WERE NEVER NOTIFIED OF THE DEFECT, OR THE AVAILABILITY OF THE REPAIR KIT. WE WOULD LIKE SOME FOLLOW UP ON THIS TO FIND OUT WHAT WENT WRONG IN ORDER TO AVOID FUTURE PROBLEMS IN COMMUNICATION. DATES OF USE: (B) (6) 2006 - (B) (6) 2010. DIAGNOSIS: VENTILATOR SPIROMETER FOR THE ANESTHESIA MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FABIUS G S ANESTHESIA MACHINE FLOWMETER OR SPIROMETER CAX DRAEGER MEDICAL, INC FABIUS SG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening