BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYSURE

    MDR report key: 3695347 · Received March 19, 2014

    Report

    Report Number
    MW5035080
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    August 9, 2013
    Report Date
    March 14, 2014
    Manufacturer
    OXYSURE
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    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).

    Description of Event or Problem · 1

    F/U REPORT REC'D 4/1/2014 FOR MW5035080: TWO VICTIMS SUSTAINED CHEMICAL BURN INJURIES. MIAMI FIRE RESCUE INCIDENT REPORT IS ATTACHED (3 PAGES). OXYSURE HAS NOT RESPONDED TO A MID-(B)(6) NOTIFICATION OF THE INCIDENT. NOTIFICATION WAS RE-SENT VIA CERTIFIED MAIL ON (B)(6). OXYGEN TANK EXPLODED / CHEMICAL BURNS (2 PTS) / NO CHEMICAL HAZARD NOW (B)6). TYPE: 1 - INCIDENT, AUTHOR: OCTAVIO SOLIS. DISP TO THE ABOVE QTH. FOUND ONE ADULT MALE AND TWO ADULT FEMALES. BOTH FEMALES HAD BURNS TO THEIR UPPER TORSOS AND ARMS. A BOX AND CANISTER WITH OXYSURE LABELS ON FLOOR. CANISTER HAD APPEARED TO HAVE EXPLODED SENDING GRAY LIQUID OVER A GOOD PART OF THE LIVING ROOM AND ALSO ON THE TWO FEMALES. BURNS APPEARED TO BE MOSTLY FIRST DEGREE. ONE PT TRANS TO MERCY ER FOR FURTHER EVAL AND TREATMENT. FPB CALLED AND INSP RESPONDED. OXYSURE UNIT WAS REPORTED TO HAVE JUST ARRIVED BY MAIL AND WAS NEW. FAMILY HAD JUST STARTED TO TRY RUNNING THE MACHINE AND IN A SHORT TIME EXPLODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162592 OXYSURE OXYSURE CAW OXYSURE 615 H0022

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O