BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYSURE

    MDR report key: 3695366 · Received March 19, 2014

    Report

    Report Number
    MW5035081
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    September 16, 2013
    Report Date
    March 14, 2014
    Manufacturer
    OXYSURE
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON (B)(6) 2014: ON (B)(6) 2013, SIX PEOPLE ARE BEING TREATED FOR MINOR BURNS AND INJURIES AFTER AN OXYGEN PACK EXPLODED AT A HIGH SCHOOL (B)(6) THIS MORNING. (B)(6) FIREFIGHTERS WERE CALLED TO A MEDICAL EMERGENCY AT (B)(6) HIGH SCHOOL, (B)(6), AT 10:11 A.M. FIREFIGHTERS ARRIVED AT 10:19 A.M. WHEN THEY ARRIVED, THEY FOUND A NURSE TREATING A STUDENT WITH AN EMERGENCY OXYGEN PACK. WHEN THE NURSE ATTEMPTED TO CHANGE CANISTERS, THE DEVICE EXPLODED, EXPOSING THE NURSE, ANOTHER STUDENT AND FIREFIGHTERS TO CHEMICALS. AS A RESULT, THE (B)(6) FIRE DEPARTMENT'S HAZMAT UNIT WAS ALERTED AT 10:44 A.M. AND ARRIVED AT 10:57 A.M. ALL SIX PEOPLE, INCLUDING THREE FIREFIGHTERS, THE SCHOOL'S NURSE, A STUDENT AND AN ASSISTANT PRINCIPAL WERE TRANSPORTED TO CENTENNIAL HOSP TO BE TREATED FOR EXPOSURE TO THE CHEMICAL AND/OR MINOR BURNS. IN ALL, AN ENGINE, TWO AMBULANCES AND THE HAZMAT UNIT RESPONDED. THE STUDENT WHO WAS INITIALLY BEING TREATED AT THE CAMPUS (B)(6) WAS NOT EXPOSED TO CHEMICAL AND WAS RELEASED. THE (B)(6) FIRE MARSHAL'S OFFICE IS INVESTIGATING THE ACCIDENT AND WORKING TO DETERMINE WHAT CAUSED THE CANISTER TO EXPLODE. THE DEVICE BURSTED, SPRAYING THE STUDENT'S SIBLING, THE NURSE, THREE FIREFIGHTERS, AND AN ASSISTANT PRINCIPAL. ACCORDING TO THE SCHOOL, THE CHEMICAL MIXTURE IS COMPARABLE TO A LIQUIFIED SODA ASH MATERIAL WHICH HAS A HIGH PH.

    Description of Event or Problem · 1

    TWO EXPLOSIONS THAT I AM AWARE OF HAVE OCCURRED WITH AN OXYGEN GENERATING DEVICE MANUFACTURED BY (B)(4). THE FDA APPROVAL NUMBER FOR THIS DEVICE IS K052396. THE FIRST EXPLOSION OCCURRED ON (B)(6) 2013 IN (B)(6). TWO PEOPLE WERE INJURED, ONE OF WHOM WAS TRANSPORTED TO (B)(6). THE SECOND EXPLOSION OCCURRED ON (B)(6) 2013, IN (B)(6) (HOME OF (B)(4)), AT (B)(6). A SCHOOL NURSE WAS USING THE DEVICE TO ADMINISTER OXYGEN TO A STUDENT. WHEN SHE ATTEMPTED TO CHANGE CARTRIDGES, THE UNIT EXPLODED, INJURING SIX PEOPLE, ALL OF WHOM WERE TRANSPORTED TO (B)(6) AND LATER RELEASED. IN MY OPINION, THE MANUFACTURER SHOULD HAVE REPORTED THESE INCIDENTS TO FDA, BUT I DO NOT KNOW IF THAT HAS HAPPENED. I CAN PROVIDE MANY DETAILS REGARDING THE (B)(6) EVENT, AND HAVE LIMITED DOCUMENTATION OF THE (B)(4) EVENT, THOUGH I HAVE REQUESTED IT. I CAN BE REACHED AT (B)(6). ALSO SEE REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163532 OXYSURE OXYSURE DQA OXYSURE 615

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O