BEUDAMED
    FDA Adverse Event Summary report: N

    GCE COMBILITE I VIPR, 40 MICRONS TYPE 0710092 FOR OXYGEN

    MDR report key: 2396786 · Received December 28, 2011

    Report

    Report Number
    3003900188-2011-00030
    Date Received
    December 28, 2011
    Product Code
    ECX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCIDENTAL SPONTANEOUS OXYGEN VALVE IGNITION CAUSING SEVERE BURNS REQUIRING BURN UNIT THERAPY. THE VALVE IS UNDERGOING INTENSIVE AND EXTENSIVE INVESTIGATION.

    Description of Event or Problem · 1

    THIS IS AN INITIAL SPONTANEOUS INCIDENT REPORT FOUND IN A NEWSPAPER IN THE (B)(6) CONCERNING A FEMALE PT, OF UNK AGE, HOSPITALISED IN AN INTENSIVE CARE UNIT. THE INITIAL INFORMATION ON THIS INCIDENT WAS RECEIVED ON (B)(4) 2011 BUT THE TYPE OF VALVE WAS NOT COMMUNICATED TO THE COMPANY UNTIL ON (B)(4) 2011 AN OXYGEN CD CYLINDER WAS USED FOR PROVIDING RESPIRATORY OXYGEN WHILE TRANSFERRING THE PT. THE OXYGEN CYLINDER WAS PLACED BETWEEN THE PT'S LEGS ON THE BED FOR TRANSFER. WHEN THE VALVE, A GCE COMBILITE I VIPR, 40 MICRONS (COMBILITE TYPE 4 (BOC PART NUMBER 19317500)) FOR OXYGEN, WAS TURNED ON, BLUE FLAMES WERE SEEN COMING OUT OF THE OUTLET. THIS CAUSED 18% BURNS (BOTH LEGS) TO THE PT AND BURNS ON THE BED AND THE FLOOR. THE PT WAS TRANSFERRED TO THE BURNS UNIT AT (B)(6) HOSPITAL. THE CURRENT CONDITION OF THE PT IS UNK. THE BURNS WERE ASSESSED AS A MEDICALLY SIGNIFICANT EVENT. THE VALVE IS WITH (B)(4) HEALTH AND SAFETY EXECUTIVE FOR INVESTIGATIONS. LINDE GAS NORTH AMERICA LLC HAS A 510 (K) FOR A SIMILAR, BUT NOT IDENTICAL, PRODUCT. FDA US WILL BE INFORMED. ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCE COMBILITE I VIPR, 40 MICRONS TYPE 0710092 FOR OXYGEN NONE ECX COMBILITE TYPE 4 4411485

    Patients

    Seq Age Sex Outcome Treatment
    1 Other