BEUDAMED
    FDA Adverse Event Summary report: N

    GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN

    MDR report key: 2143474 · Received March 16, 2011

    Report

    Report Number
    3003900188-2011-00011
    Date Received
    March 16, 2011
    Date of Event
    January 29, 2011
    Manufacturer
    LINDE GAS NORTH AMERICA LLC
    Product Code
    ECX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. EVAL: ACCIDENTAL IGNITION AND FIRE IN OXYGEN VALVE.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS MEDICAL INCIDENT REPORT FROM A MAINTENANCE ENGINEER AT A HOSP IN BRAZIL CONCERNING A (B)(6) MALE PORTER AT THE HOSP. ON (B)(6) 2011 WHEN THE PORTER TRIED TO OPEN THE COMBILITE TYPE (B)(4) CYLINDER VALVE (GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN) OF AN OXYGEN CYLINDER USED FOR TRANSPORTATION A FIRE STARTED AND BURNT HIS HAND. THE PORTER HAD 1ST AND 2ND DEGREE BURNS AND WAS ASSISTED IN THE HOSP WHERE HE WORKS AND WAS SENT HOME FOR 5 WORKING DAYS. TREATMENT GIVEN FOR THE BURNS WERE ASEPTIC AND DRESSING WITH SILVER SULFADIAZINE. THEREAFTER HE WAS RECOVERED AND IS BACK TO WORK IN THE SAME ACTIVITIES AS BEFORE THE INCIDENT. ADD'L INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN NONE ECX LINDE GAS NORTH AMERICA LLC 0710160 4195896

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR