BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCE COMBILITE VALVE, CYLINDER

    MDR report key: 3799627 · Received March 21, 2014

    Report

    Report Number
    3003900188-2014-00001
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    January 12, 2014
    Report Date
    March 21, 2014
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCIDENTAL SPONTANEOUS IGNITION OF OXYGEN VALVE. EXTENSIVE INVESTIGATION IN COLLABORATION WITH VALVE MANUFACTURER. NO PATIENT OR PERSONNEL HARM.

    Description of Event or Problem · 1

    IGNITION IN GCE COMBILITE VALVE ON (B)(6) 2014 AT THE FILLING SITE IN (B)(6). NO PATIENTS WERE INVOLVED AS THE INCIDENT OCCURRED AT THE FILLING SITE. CYLINDER WAS SENT TO (B)(6) FOR FURTHER INVESTIGATION. PROCESS TO INVESTIGATE ROOT CAUSE AND ELIMINATION OF REOCCURRENCE HAS BEEN INITIATED BY WORKING TOGETHER WITH GCE. GCE (GAS CONTROL EQUIPMENT) IS THE MANUFACTURER FOR THE PRESENT DEVICE IS EUROPE. (B)(6) HAS A 510 (K) FOR A SIMILAR PRODUCT. CYLINDER SERIAL NUMBER: (B)(4), DOM: 05/01/2013, VALVE NUMBER: 090798217, DOM: (B)(6) 2009. EXPIRY DATE: 11/26/2016. ASSESSMENT REPORT STATE THAT INCIDENT COULD HAVE OCCURRED WHEN THE CUSTOMER USED IT NEXT. AS THE CYLINDER HAD BEEN RETURNED TO BOC FOR RE-FILLING, AND HAD NOT BEEN INSPECTED PRIOR TO THE IGNITION OCCURRING, THERE IS NO EVIDENCE IF THE CYLINDER HAD BEEN PREVIOUSLY USED BY THE CUSTOMER OR WHETHER THERE WAS ANY EXTERNAL EVIDENCE OF DAMAGE OR CONTAMINATION BEFORE THE VALVE WAS INADVERTENTLY TURNED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169298 GCE COMBILITE VALVE, CYLINDER NA ECX 241955

    Patients

    Seq Age Sex Outcome Treatment
    1