LIFE SUPPORT PRODUCTSOXYGEN REGULATOR

Additional Manufacturer Narrative

IT WAS REPORTED THAT A FIRE ORIGINATED FROM AN OXYGEN REGULATOR WHEN THE OXYGEN CYLINDER WAS TURNED ON. THE REPORTED EVENT OCCURED INSIDE THE (B)(6) WHILE EMTS WERE TRANSPORTING A PATIENT. THE COMPANY'S L270-050 MODEL REGULATORS HAVE NOT BEEN MANUFACTURED SINCE 1999. THE LABELING OF THE L270-050 REGULATOR THAT WAS INVOLVED IN THE EVENT SHOWS THAT IT WAS AN ALUMINUM REGULATOR THAT HAD BEEN RETROFITTED WITH BRASS INTERNAL COMPONENTS (SPECIFICALLY, A BRASS INLET FITTING, A SINTERED BRONZE INLET FILTER, BRASS BAFFLE, AND A BRASS PISTON) AS PART OF A RECALL ACTION THAT WAS CLOSED BY THE COMPANY AND FDA IN 2000. THE COMPANY WAS AVAILABLE TO VISUALLY INSPECT THE REGULATOR. HOWEVER, THE REGULATOR WAS NOT RELEASED TO THE COMPANY TO CONDUCT IT'S OWN TESTING. IT WAS REPORTED TO THE COMPANY THAT ONE EMT RECEIVED 2ND DEGREE BURNS TO HIS HAND AND WAS TREATED AND RELEASED. THE PATIENT WHO WAS BEING TRANSPORTED HAD SINGED HAIR AND WAS EXAMINED AND RELEASED. THE ONGOING INVESTIGATION INTO THE EVENT SUGGESTS THAT THE REGULATOR HAD A BURN PATTERN INDICATING THAT THE FIRE STARTED ON THE INLET FILTER. HIGH PRESSURE OXYGEN FORCES FIRE TO PROPAGATING THE DIRECTION OF FLOW. THE BOTTOM OF THE INLET STEM WHICH HOLDS THE FILTER WAS BURNED AND ALL ITEMS DOWNSTREAM FROM THIS POINT WERE ALSO BURNED. UPSTREAM ELEMENTS OF THE SYSTEM DID NOT EXHIBIT THERMAL DAMAGE. BECAUSE THE SINTERED BRONZE THAT LINES THE GAS PATHWAY DOES NOT BURN ON IT'S OWN, IT IS HIGHLY LIKELY THAT CONTAMINANTS WERE PRESENT ON THE FILTER AND WERE THE SOURCE OF THE IGNITION. LABELING ON THE PRODUCT STATES THAT THE INTRODUCTION OF CONTAMINANTS MAY CAUSE COMBUSTION AND INSTRUCTS THE USER TO OPEN THE POST VALVE SLOWLY AS THIS MAY LEAD TO COMBUSTION IF CONTAMINANTS ARE PRESENT. THE IFU FOR THE PRODUCT STATES TO INSPECT THE UNIT EVERY TWO MONTHS AND HAVE THE UNIT SERVICED EVERY TWO YEARS. THE INSPECTION, SERVICE, AND MAINTENANCE HISTORY FOR THIS REGULATOR OVER THE LAST 20 YEARS IS PRESENTLY UNKNOWN TO THE COMPANY. THE COMPANY IS UNAWARE OF ANY OTHER REPORTS OF FIRES WITH IT'S RETROFITTED ALUMINUM REGULATORS OR IT'S BRASS REGULATORS IN THE LAST 20 YEARS. THE COMPANY IS CONTINUING IT'S INVESTIGATION.

Description of Event or Problem

A FIRE OCCURED IN AN OXYGEN REGULATOR.