BEUDAMED
    FDA Adverse Event Summary report: N

    GCE COMBILITE VIPR TYPE 4, 40 MICRON FILTER

    MDR report key: 2464208 · Received February 17, 2012

    Report

    Report Number
    3003900188-2012-00001
    Date Received
    February 17, 2012
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYTICAL REPORT DOES NOT REVEAL THE EXACT MECHANISM FOR THE IGNITION OF THE VALVE. THUS THE ANALYSIS RESULTS BRING LIMITED ADDITIONAL INFORMATION, ESPECIALLY FOR THE UNITED STATES MARKET WHERE NO IGNITIONS HAVE OCCURRED. PER REQUEST FROM FDA AND IN ORDER TO BE COMPLETE ANALYSIS DATA SUMMARY AND CONCLUSIONS FROM THE ASD REPORT NO. (B)(4) DATED (B)(4) 2012, HAS BEEN ADDED TO THE CASE. SUMMARY: THE INVESTIGATION CONFIRMED THAT AN IGNITION HAD OCCURRED WHICH HAD CAUSED SIGNIFICANT DAMAGE TO THE EXTERNAL CYLINDER SHELL, PLASTIC VALVE GUARD AND THE VALVE ITSELF. SIGNIFICANT FINDINGS: THE VALVE GUARD WAS COMPLETELY CONSUMED IN THE FIRE. THE CYLINDER VALVE WAS CONFIRMED TO BE IN THE FULLY CLOSED POSITION. THE CYLINDER VALVE WOULD APPEAR TO HAVE BEEN CLOSED AFTER THE IGNITION, AS IT WAS FULLY CLOSED WITHOUT THE SEAT, AND PROBABLY CAUSED THE MARKS WITNESSED ON THE FILTER. THE FLOW HEAD WAS SET AT 4 LITRES/MIN. THE WINDOW, SCALE AND TUBE COMPONENTS WERE EJECTED FROM THE GAUGE. THE CENTRE COILS OF THE BOURDON TUBE WERE FOUND SEPARATELY. THE SOFT VALVE SEAT WAS COMPLETELY MISSING AND THERE WAS EXTRUSION OF THE NYLON THRUST WASHER ON THE SHUT OFF VALVE (SOV) UPPER SPINDLE. THE RESIDUAL PRESSURE VALVE (RPV) ¿O¿ RINGS WERE MISSING. THERE WAS SIGNIFICANT INTERNAL DAMAGE TO THE REGULATOR RELIEF VALVE AND FLOW HEAD. THE TUBULAR FILTER WAS BLACKENED AND POSSIBLY IGNITION DAMAGED (TO BE CONFIRMED). THE SCHRADER OUTLET WAS INTERNALLY UNDAMAGED. THE FILL PORT WAS ALSO RELATIVELY UNSCATHED INTERNALLY, THE NON-RETURN VALVE (NRV) MECHANISM WAS ONLY SLIGHTLY HEAT DAMAGED. CONCLUSIONS: THE CAUSE OF THE FIRE COULD NOT BE CONCLUSIVELY ESTABLISHED BY THE PRELIMINARY INVESTIGATION. FURTHER WORK IS ONGOING AT (B)(6) UNIVERSITY. NO FURTHER ACTION WAS TAKEN BY THE COMPANY OR WAS REQUIRED BY (B)(4). EVALUATION: SPONTANEOUS IGNITION IN OXYGEN VALVE, EXTENSIVE INVESTIGATIONS AND ANALYSIS OF THE ROOT CAUSE. NO CONCLUSIVE CAUSE HAS BEEN ESTABLISHED DURING THE PRELIMINARY INVESTIGATIONS, FURTHER INVESTIGATIONS ONGOING.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS INCIDENT REPORT FROM THE PRACTICE MANAGER AT (B)(6). ON (B)(6) 2012, AN IGNITION OCCURRED IN AN OXYGEN HX CYLINDER VALVE FOLLOWING OPENING OF THE VALVE. THE VALVE WAS A GCE COMBLITE VIPR TYPE 4 VALVE, MODEL NUMBER: BOC PART 19317517. THE IGNITION OCCURRED BEFORE THE MASK WAS FITTED TO THE PATIENT. NO PATIENT OR HEALTHCARE PROFESSIONAL WAS INJURED. THE FIRE BRIGADE ATTENDED THE SCENE. THE CYLINDER HAS BEEN RETRIEVED AND SENT TO (B)(6) SERVICE DEPARTMENT (ASD) FOR INVESTIGATION. THE EXACT SERIAL NUMBER IS CURRENTLY NOT KNOWN AS FIRE DAMAGE MAKES IT DIFFICULT TO READ THESE NUMBERS. HOWEVER, PACKAGE NUMBER HAS BEEN LOCATED TO ONE OF 11 CYLINDERS BASED ON DELIVERY HISTORY TO THE CUSTOMER AND EXPIRY DATE OF THE CYLINDER WHICH COULD BE DETERMINED. THE SERVICE HISTORY OF THOSE 11 VALVES HAS ALSO BEEN RETRIEVED. EVALUATION SUMMARY FROM ANALYSIS REPORT ADDED TO CASE. ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCE COMBILITE VIPR TYPE 4, 40 MICRON FILTER NONE ECX BOC PART NUMBER 19317517

    Patients

    Seq Age Sex Outcome Treatment
    1