BEUDAMED
    FDA Adverse Event Other Summary report: N

    BYJ

    MDR report key: 3063093 · Received April 12, 2013

    Report

    Report Number
    3004822415-2013-00005
    Event Type
    Other
    Date Received
    April 12, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K860937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY'S REGULATORY PERSONNEL FROM (B)(6) VISITED THE HOME OF THE PT WHOM WAS INVOLVED IN THE FIRE, TO EVALUATE THE DAMAGED SUBJECT HELIOS U46EU VESSEL ON (B)(6) 2013, JUST THREE DAYS AFTER THE COMPANY WAS MADE AWARE OF THE FIRE. IT WAS NOTED THE SUBJECT VESSEL'S PLASTICS AND ALUMINUM COILS WERE MELTED. THE QDV POPPET HAD MELTED AND THE BODY WAS CRACKED. ALSO NOTED, THE SUBJECT VESSEL WAS FOUND TO BE NOT ACTUALLY IN AN OUTSIDE STRUCTURE, BUT JUST OUTSIDE THE PT'S HOME IN A REAR GARDEN AREA. THE SUBJECT VESSEL HAD A BLACK PLASTIC BAG PLACED OVER THE TOP OF THE SHROUD, AND WAS BEING HELD DOWN WITH A CARDBOARD BOX. THE CAUSE OF THE FIRE IS STILL BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED OF AN ALLEGED FIRE IN (B)(6), ON (B)(6) 2013. INCLUDED IN THE DAMAGE OF THE FIRE WAS THE SUBJECT HELIOS U46EU STATIONARY LIQUID OXYGEN VESSEL (SN (B)(4)). THE ALLEGED INCIDENT WAS DESCRIBED AS THE FOLLOWING: "THE VESSEL WAS STORED IN AN OUTSIDE STRUCTURE AND THE PT (WHO IS A SMOKER) WAS REPORTEDLY IN THE BATH AT THE TIME OF THE FIRE. THERE WERE NO INJURIES AND THE (B)(6) WERE CALLED TO HANDLE THE FIRE. A NEIGHBOR REPORTED THAT THEY FIRST SAW WHITE SMOKE, WHICH EVENTUALLY TURNED TO BLACK SMOKE, AND THERE WAS A SOUND LIKE A TRAIN COMING FROM THE FIRE." THE SUBJECT VESSEL DID SUSTAIN DAMAGES FROM THE FIRE CONSISTING OF AN EXTREMELY BURNED DEWAR, ALL PLASTICS AND PLUMBING COILS HAVE BEEN MELTED AND THE QDV IS CRACKED. THE REMAINS OF THE ELG ARE MELTED PLASTIC AND A BURNED CIRCUIT BOARD. THE MELTED PLASTIC BATTERY HOLDER ALSO STILL CONTAINS THE 9V BATTERY. DETAILS OF THE SOURCE OF THE IGNITION OF THE FIRE ARE STILL BEING INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158206 BYJ UNIT, LIQUID-OXYGEN, PORTABLE BYJ CAIRE, INC. HELIOS U46EU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other