BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS IFILL

    MDR report key: 6142736 · Received December 2, 2016

    Report

    Report Number
    2515872-2016-00002
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 4, 2016
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304000860
    PMA / PMN Number
    K053240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RECENTLY RETURNED TO DEVILBISS HEALTHCARE AND IS BEING EVALUATED TO DETERMINE THE FACTS AND EXTEND OF THE EVENT, AS WELL AS THE ROOT CAUSE. PRELIMINARY EXAMINATION OF THE DEVICE SUGGESTS EXTERNAL VARIABLES AND ACTIONS MAY HAVE CONTRIBUTED TO THE EVENT. THE UNIT IS UNDERGOING A COMPREHENSIVE EVALUATION AND ANALYSIS; NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED FROM A LONG TERM CARE FACILITY IN FRANCE. THERE IS NO ADVERSE EVENT OR INJURY ASSOCIATED WITH THE COMPLAINT. A NURSE WAS REMOVING/DISCONNECTING A FULL IFILL OXYGEN CYLINDER FROM THE IFILL OXYGEN TRANSFILL UNIT, AT WHICH TIME SHE HEARD A LOUD SOUND AND SAW A BRIEF FLAME COMING FROM THE OXYGEN CONNECTING PORT. THE NURSE IS UNSURE IF THE IFILL UNIT WAS RUNNING OR HAD STOPPED AT THE TIME SHE DISCONNECTED CYLINDER BUT IT NOTED THE IFILL UNIT WAS PLUGGED INTO THE WALL. THE NURSE STATED SHE HEARD A LOUD SOUND AND SAW A BRIEF FLAME, WHICH CAUSED THE NURSE TO DROP THE CYLINDER TO THE FLOOR. ONCE THE CYLINDER WAS ON THE FLOOR THE EVENT ENDED; SHE REPORTED NO OTHER ISSUES WITH THE CYLINDER OR THE IFILL UNIT. THE CYLINDER AND TRANSFILL DEVICE WERE QUARANTINED AND THE OXYGEN SUPPLIER CONTACTED. THE FACILITY ACKNOWLEDGES THE ROUTINE USE OF CLEANING AGENT ON THE IFILL CYLINDER THAT CONTAINS HIGH CONCENTRATIONS OF PROPRANOLOL AND ETHANOL. THE CLEANING AGENT IS HIGHLY FLAMMABLE AND IS CONTRAINDICATED FOR USE WITH OXYGEN EQUIPMENT. THERE WERE NO INJURIES OR DAMAGE RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792114 DEVILBISS IFILL OXYGEN FILLING SYSTEM CAW DEVILBISS HEALTHCARE LLC 535I 00885304000860

    Patients

    Seq Age Sex Outcome Treatment
    1