BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 190027 · Received September 25, 1998

    Report

    Report Number
    MW1014678
    Event Type
    Other
    Date Received
    September 25, 1998
    Date of Event
    March 20, 1998
    Report Date
    August 5, 1998
    Manufacturer
    AIR PRODUCTS AND CHEMICALS, INC.
    Product Code
    ECX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS HOOKED UP TO ANESTHESIA MACHINE. AFTER A COUPLE OF MINUTES PT DISCOVERED THE "SMELL" WHICH IRRITATED/BURNED HER THROAT. THE SMELL WAS NOT DISCOVERED PRIOR TO ADMINISTRATION OF OXYGEN BECAUSE SHE HAD BEEN ON THIS OXYGEN FOR "SOME UNDETERMINED NUMBER OF MINUTES" VIA NASAL CANNULA BEFORE THE SMELL AND IRRITATION APPEARED. OTHER PEOPLE EXPOSED TO ODOR INCLUDED ANESTHESIOLOGIST, 2 CLINIC EMPLOYEES, ONE OF WHICH IS PREGNANT, AND THE DOCTOR PERFORMING THE SURGERY. ALL COMPLAINED OF BURNING EYES AND NOXIOUS ODOR. THE PREGNANT EMPLOYEE WAS SEEN BY A PHYSICIAN AND FOUND TO BE O.K. PT WAS ALSO SEEN BY DOCTOR 3/25 AND 3/26 AND WAS TOLD SHE WAS FINE. PT COMMENTED THAT SHE WAS SUFFERING NO AFFECT AND FELT FINE. UPON ARRIVAL OF CYLINDER CO EMPLOYEES WHO WERE RESPONDING TO COMPLAINT, THEY TOO HAD NOTICED THE ODOR AT THE ANESTHESIA MACHINE OUTLET AND IN MANIFOLD ROOM. ONE CLINIC EMPLOYEE HAD SMELLED THE CYLINDERS AFTER THE INCIDENT AND FOUND NO ODOR OTHER THAN "A METAL SMELL LIKE YOU GET WHEN YOU BREATHE FROM A SCUBA TANK." CLINIC EMPLOYEE THEN RELEASED CYLINDERS TO CO TO SEND THEM OUT FOR ANLYSIS BY AN INDEPENDENT LAB. THE OWNERS OF THE ANESTHESIA MACHINE HAD ALSO TAKEN GAS SAMPLES FROM RESIDUAL GAS IN PIPES AND HOSES, BUT THEY DIDN'T KNOW WHAT LAB THEY WERE GOING TO SEND THE SAMPLES TO. ALL EQUIPMENT WAS QUARANTINED IN A LOCKED ROOM. IT IS OPEN TO ATMOSPHERE, BUT THERE IS NO ODOR TODAY. ALL PEOPLE THAT WERE EXPOSED ARE REPORTED AS FINE. CLINIC ALSO REPORTED THAT THESE SAME CYLINDERS WERE USED TO PERFORM GENERAL ANESTHESIA ON 2 OTHER CASES WITH NO PROBLEMS. DOCTOR PREPARED OSHA - EXPOSURE INCIDENT FORM ON 3/20/98. ANESTHESIA MACHINE REPORT, UNK. CYLINDER REPORT, 4/2-4/6/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK OXYGEN CYLINDER ECX AIR PRODUCTS AND CHEMICALS, INC. * *
    2 UNK OXYGEN CYLINDER ECX AIR PRODUCTS AND CHEMICALS, INC. * *
    3 UNK OXYGEN CYLINDER ECX AIR PRODUCTS AND CHEMICALS, INC. * *
    4 UNK OXYGEN CYLINDER ECX AIR PRODUCTS AND CHEMICALS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other