BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRON MEDICAL OXYGEN GAS REGULATOR

    MDR report key: 3095907 · Received May 6, 2013

    Report

    Report Number
    MW5030023
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ACCUTRON, INC.
    Product Code
    CAN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED ON BEHALF OF HIS EMPLOYEE WHO EXPERIENCED AN ADVERSE REACTION FOR THE ACCUTRON OXYGEN GAS REGULATOR. REPORTER STATED AROUND 8:15AM ON (B)(6) 2013, HIS EMPLOYEE (B)(6) WAS IN THE OFFICE TURNING ON THE GAS TANKS AS SHE NORMALLY DOES WHEN SHE CAME INTO WORK. THE REPORTER SAID HE THEN HEARD A LARGE "BOOM", SAW A FLASH FIRE WITH SMOKE AND DUST, AND HEARD HIS EMPLOYEE SCREAM LOUDLY. THE REPORTER SAID HE INSTRUCTED THE EMPLOYEE, AND OTHER EMPLOYEES, OUT OF THE BUILDING. HE THEN SAID HE WENT BACK INSIDE TO TURN OFF THE OXYGEN TANK. THE REPORTER STATED THE ONE EMPLOYEE WHO TURNED ON THE MACHINES RECEIVED FIRST AND SECOND DEGREE BURNS ON HER LEFT ARM FROM HER ELBOW TO HER WRIST FROM THE EXPLOSION. HE STATED SHE WAS TREATED IN THE HOSPITAL THAT DAY AND DISCHARGED THE SAME DAY. THE EXPLOSION IS STILL UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197324 ACCUTRON MEDICAL OXYGEN GAS REGULATOR OXYGEN GAS REGULATOR CAN ACCUTRON, INC. 3500633

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other