BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYLITE MINI SYSTEM

    MDR report key: 37610 · Received September 11, 1996

    Report

    Report Number
    2024040-1996-00001
    Event Type
    Injury
    Date Received
    September 11, 1996
    Date of Event
    August 12, 1996
    Report Date
    September 11, 1996
    Manufacturer
    CHAD THERAPEUTICS
    Product Code
    ECX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "A PT WAS CAUGHT ON FIRE AT A PARKING METER NEXT TO A PARKING LOT (USING CO SYSTEM)." IT WAS INITIALLY REPORTED THAT THE PT RECEIVED 2ND AND 3RD DEGREE BURNS ON HER BACK AND ARMS. THE FIRE MARSHALL'S REPORT STATED THAT "THE PT HAD GOTTEN OUT OF HER CAR AND WAS WALKING TO THE PARKING METER. SHE WAS GOING TO PUT SOME COINS IN THE PARKING METER WHEN ALL OF A SUDDEN HER BLOUSE AND THE OXYGEN TANK UNIT THAT SHE WAS WEARING JUST BURST INTO FLAMES." THE FIRE MARSHALL ALSO STATED "THAT THEY USED A DRY POWDER FIRE EXTINGUISHER TO EXTINGUISH THE BURNT CLOTHING THAT HAD TAKEN OFF AND THE OXYGEN TANK SHE WAS WEARING." PRELIMINARY INVESTIGATION BY THE FIRE MARSHALL AND THE CRIME LAB REVEALED THE DEVICE WAS FUNCTIONAL AT THE TIME OF THE INVESTIGTION (SEE ATTACHMENT 1). THE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. THE SYSTEM IS BEING HELD PENDING LITIGATION AND IS CURRENTLY UNAVAILABLE FOR INVESTIGATION. UPON COMPLETING THE LITIGATION THE UNIT WILL BE RELEASED TO THE MFR OR DISTRIBUTOR FOR FURTHER EVAL AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYLITE MINI SYSTEM OXYLITE MINI SYSTEM ECX CHAD THERAPEUTICS * A151

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization