BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGEN COMPRESSED GAS E-CYLINDER

    MDR report key: 7633578 · Received April 27, 2018

    Report

    Report Number
    7633578
    Event Type
    Death
    Date Received
    April 27, 2018
    Date of Event
    April 20, 2018
    Report Date
    April 27, 2018
    Manufacturer
    MEDCYL
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) SW MADE VISIT ON (B)(6) 2018 AND WAS NOTIFIED BY (B)(6) THAT PT WAS AIRLIFTED TO (B)(6) ON (B)(6) 2018 DUE TO BURNS ON FACE AND ARMS. (B)(6) STATES PT TURNED OFF O2 BUT DIDN'T WAIT TO SMOKE. SPOKE WITH OPERATOR AT (B)(6) WHO CONFIRMED PT ADMIT DATE (B)(6) 2018 AND DEATH DATE (B)(6) 2018. LOCAL POLICE REPORT STATED THAT PT WAS INJURED BY MINOR EXPLOSION/FIRE AND SUFFERED THIRD DEGREE BURNS. EITHER OXYGEN E TANK OR M6 TANK WAS INVOLVED IN PT INJURY/DEATH, UNABLE TO ASCERTAIN FOR SURE BECAUSE WE ARE UNABLE TO ENTER HOME TO INVESTIGATE EQUIPMENT. REF UF# (B)(4) FOR OXYGEN CYLINDER M6 TANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313792 OXYGEN COMPRESSED GAS E-CYLINDER OXYGEN COMPRESSED GAS E-CYLINDER CAW MEDCYL 1180681

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H HUMIDIFIER ADAPTER | NEB KIT, AEROSOL MASK | NEBULIZER | O2 CART| OCD| OCD POUCH| OXYGEN WRENCHS| REGULATOR