BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANESTHESIA MACHINE

    MDR report key: 31371 · Received March 20, 1996

    Report

    Report Number
    MW4001108
    Event Type
    Malfunction
    Date Received
    March 20, 1996
    Report Date
    January 10, 1996
    Manufacturer
    NORTH AMERICAN DRAGER
    Product Code
    GSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR RECEIVED CALL FROM A SURGERY TECHNICIAN. HE INFORMED MEDICAL EQUIPMENT REPAIR OF AN APPARENT ANESTHESIA MACHINE MALFUNCTION. IT HAD REPORTEDLY STOPPED DELIVERING OXYGEN TO THE PT. THEY IMMEDIATELY SWITCHED TO BOTTLED OXYGEN WITHOUT SUCCESS. THERE ARE CONFLICTING REPORTS ABOUT WHETHER THE INCOMING OXYGEN GAUGE DISPLAYED PROPER PRESSURE OR NOT. IN HOPES OF RESOLVING THE PROBLEM, A TECHNICIAN LEFT THE ROOM TO GET A NEW BOTTLE OF OXYGEN; BUT, BY THE TIME HE RETURNED, THE ANESTHESIA MACHINE HAD RETURNED TO NORMAL OPERATION. SINCE THE PROCEDURE WAS NEARLY FINISHED, THE MACHINE WAS USED TO FINISH THE CASE. AS SOON AS THE CASE WAS COMPLETED THE ANESTHESIA MACHINE WAS REMOVED FROM SERVICE. A FOLLOW-UP CALL ON 2/9/96 REVEALED THAT THE MACHINE IN QUESTION HAS OPERATED PERFECTLY SINCE THE INITIAL PROBLEM WAS REPORTED AS HAVE THEIR OTHER THREE UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHESIA MACHINE ANESTHESIA MACHINE GSZ NORTH AMERICAN DRAGER

    Patients

    Seq Age Sex Outcome Treatment
    1 *