BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCE

    MDR report key: 23016051 · Received September 10, 2025

    Report

    Report Number
    3011895992-2025-00004
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    July 8, 2025
    Report Date
    September 10, 2025
    Manufacturer
    GAS CONTROL EQUIPMENT LTD
    Product Code
    CAW
    UDI-DI
    08592346004337
    PMA / PMN Number
    K162433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSICAL INDICATORS ARE OF AN EXTERNAL CANNULA IGNITION THAT HAS BURNED BACK TO THE CANNULA PORT.:EXTERNAL BURN TO CARRY CASE ELEMENTS AND DISCOLORATION OF THE CANNULA PORT HOUSING AND OXIDISATION OF ALUMINIUM CANNULA NOZZLE, ALL OBSERVED. CAUSE OF SUCH WOULD BE INAPPROPRIATE USAGE BY END USER CONTRARY TO IFU WARNINGS. DESPITE GCES VALIDATION THAT CANNULA PORT SHOULD EXTINGUISH A CANNULA FIRE AND STOP IT ENTERING THE DEVICE, IT APPEARS THAT THIS FIRE'S FUEL ELEMENT HAS CONTINUED INTO THE CONCENTRATOR DEVICE AND CAUSED A CONTINUED BURN BACK WITH OXYGEN BEING SUPPLIED BY THE DEVICE UNTIL FUEL ELEMENT WAS DEPLETED. EVIDENCE APPEARS TO HAVE BEEN SOMEWHAT AFFECTED BY METHOD OF FIRE EXTINGUISHING PERFORMED DURING/AFTER THE EVENT, WITH WATER DAMAGE TO MANY COMPONENTS. FURTHER CLARIFICATION OF THE INCIDENT , IN TERMS OF POSSIBLE EXTERNAL FIRE SOURCE, OTHER MEDICAL DEVICES USED WITH THE CONCENTRATOR ( CANNULA/ MASK AND TUBE), CLEAN UP OF DEVICE , FIRE EXTINGUISHING ETC FROM (B)(6) AND THE INCIDENT'S NURSING HOME PERSONNEL.

    Description of Event or Problem · 0

    REPORT FROM OXYGEN CONCENTRATOR DEVICE DISTRIBUTOR INDICATES INCIDENT OCCURING ON NURSING HOME , (B)(6) DESCRIBING 'BURNING BATTERY INSIDE THE DEVICE/ BURNING DEVICE' AND 'THE PATIENT WENT TO EAT AND THE MOBILE CONCENTRATOR SMOKED AND CAUGHT FIRE'. INSPECTION OF RETURNED DEVICE SHOWS EXTERNAL SIGNS OF FIRE TO IT'S CARRY CASE AND BURN HOLE THROUGH THE CANNULA HOUSING AND CARRY CASE AT THAT POINT, WHICH WOULD HAVE HAD POTENTIAL TO CAUSE HARM WHEN IT OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506850 GCE ZEN-O CAW GAS CONTROL EQUIPMENT LTD RS-00500 08592346004337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown