BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIV SYSTEM WITH GCE - VIPR VALVE

    MDR report key: 3808205 · Received April 4, 2014

    Report

    Report Number
    3003900188-2014-00002
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    April 4, 2014
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: ACCIDENTAL SPONTANEOUS IGNITION IN OXYGEN VALVE. ROOT CAUSE UNKNOWN, INVESTIGATIONS ONGOING. MAIN MANUFACTURER INFORMED AND INVOLVED IN THE ANALYSIS PROCESS. (B)(6) INFORMED.

    Description of Event or Problem · 1

    SPONTANEOUS IGNITION OF A LIV SYSTEM WITH GCE VIPR VALVE FROM YEAR 2009 REPORTED (B)(6) 2014 FROM A (B)(6). NO PATIENTS CAME TO HARM. VIPR SERIAL NUMBER (B)(6). FILED 2014 IN THE (B)(6). IV 1000 CONOXIA CYLINDER HAD A BARCODE (B)(6). A PATIENT WAS TREATED AT THE EMERGENCY WARD AT A HOSPITAL IN (B)(6). THE PATIENT WAS CONNECTED TO THE HEART DEFIBRILLATOR. THE PATIENT NEEDED OXYGEN AND THE HOSE OF THE OXYGEN MASK WAS ATTACHED TO THE OXYGEN CYLINDER. WHEN ATTACHING THE LUG OF THE CONE OF THE OXYGEN BOTTLE THERE WAS AN IMMEDIATE AND LOUD BANG AND FLAMES AND A PRESSURE WAVE. A MASSIVE HISSING FROM THE OXYGEN BOTTLE WAS HEARD. THE FIRE WENT TO THE DEFIBRILLATOR AND ITS CABLE MOUNTED ON THE DEVICE OVER. THE PATIENT WAS IMMEDIATELY TAKEN OUT OF THE ROOM. NO PATIENTS OR STAFF CAME TO HARM. THE CYLINDER WILL BE PICKED UP FOR INVESTIGATION. ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204818 LIV SYSTEM WITH GCE - VIPR VALVE NONE ECX

    Patients

    Seq Age Sex Outcome Treatment
    1