BEUDAMED
    FDA Adverse Event Summary report: N

    CO2 TANK

    MDR report key: 4172019 · Received March 25, 2014

    Report

    Report Number
    1419185-2014-00002
    Date Received
    March 25, 2014
    Date of Event
    January 22, 2014
    Report Date
    March 25, 2014
    Product Code
    ECX
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER (B)(6) WAS CONTACTED AND SHE STATED "I AM UNABLE TO DETERMINE THE MFR OF THE TANK. THERE WERE WORDS AND NUMBERS STAMPED INTO THE METAL OF THE TANK. THEY WERE VERY DIFFICULT TO READ. WE WERE ABLE TO MAKE OUT THE WORD OHIO, BUT THAT WAS ABOUT IT. THAT DOES NOT NECESSARILY MEAN THE TANK WAS MADE BY YOUR COMPANY. I AM NOT SURE HOW THE MEDWATCH FOLKS LINKED THE TANK TO YOUR COMPANY. IT COULD BE AN ERROR." OHIO MEDICAL DOES NOT MFR OR DISTRIBUTE CO2 TANKS.

    Description of Event or Problem · 1

    POST OP PATIENT CONNECTED TO PORTABLE MEDICAL GAS TANK FOR TRANSPORT. OXYGEN SATURATION DROPPED. PATIENT CARDIAC ARRESTED. FOUND THAT PATIENT WAS CONNECTED TO A CO2 TANK. PATIENT WAS SUCCESSFULLY RESUSCITATED. THE CO2 TANK HAD A GREEN PLASTIC ADAPTER (CONE SHAPED ADAPTER) ON THE REGULATOR NOZZLE. GREEN ADAPTERS INDICATE OXYGEN. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? DELIVERY OF OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174366 CO2 TANK CYLINDER, COMPRESSED GAS AND VALVE ECX

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR