BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXFER

    MDR report key: 234454 · Received July 22, 1999

    Report

    Report Number
    MW1016877
    Event Type
    Malfunction
    Date Received
    July 22, 1999
    Date of Event
    July 20, 1999
    Manufacturer
    LUXFER GAS CYLINDERS
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    7/20/99: INCIDENT OCCURRED: FIBER WRAP CYLINDER BLEW OUT THE SAFETY VALVE CAUSING DAMAGE TO A PT'S RESIDENCE. VISIT WAS MADE BY HOME SVC STAFF TO THE RESIDENCE, TO DISCOVER THE NATURE OF THE PROBLEM. DAMAGED CYLINDER WAS RETRIEVED. 7/21/99: VISIT WAS MADE TO THE PT'S RESIDENCE BY RPTR TO MAKE PHOTOGRAPHS OF THE DAMAGE AND TO CHECK THE REMAINING CYLINDER LOT NUMBERS FOR POTENTIAL ADD'L PROBLEMS. NO OTHER PROBLEMS WERE DISCOVERED AT THIS TIME. HOME OXYGEN SUPPLY CO INFORMED THE PT THAT SHE WOULD BE COMPENSATED FOR THE DAMAGE. 7/22/99: TELEPHONE REPORT WAS MADE TO THE FDA, BY RPTR AT HOME OXYGEN CO REGARDING THE INCIDENT. THE OWNER OF THE OXYGEN SUPPLY CO AND THE QUALITY MGR FROM LUXFER (CYLINDER MFR) VISITED HOME OXYGEN SUPPLY CO TO DISCUSS THE INCIDENT WITH STAFF. HOME OXYGEN SUPPLY CO WAS INFORMED, IN THIS MEETING, THAT THE WRONG SAFETY PLUGS HAD BEEN INSTALLED IN SOME OF LUXFER'S CYLINDERS, CAUSING THE PROBLEM. LUXFER FURTHER POINTED OUT THAT THESE CYLINDERS COULD BE IDENTIFIED BY THE ABSENCE OF A 3000 PSI STICKER ON THE CYLINDER VALVE POST. IT WAS FURTHER DETERMINED THAT THERE WERE POTENTIALLY MORE OF THE UNSAFE CYLINDERS IN OTHER PT'S HOMES AND THAT THEY SHOULD BE FOUND AND SWITCHED OUT BEFORE OTHER INCIDENTS COULD OCCUR. STAFF VOLUNTEERED THAT THEY WOULD BE CERTAIN THAT HOME OXYGEN SUPPLY CO IS SUPPLIED WITH ENOUGH CYLINDERS TO ACCOMPLISH THIS OBJECTIVE IN A TIMELY FASHION. THE ACTION PLAN IS TO IDENTIFY THE PTS ASAP AND SWITCH THE CYLINDERS ASAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXFER OXYGEN CYLINDER ECX LUXFER GAS CYLINDERS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other