Description of Event or Problem · 1
THIS IS A SPONTANEOUS MEDICAL DEVICE INCIDENT REPORT FROM (B)(6) RECEIVED BY LINDE ON 12/14/2015, CONCERNING A SPONTANEOUS IGNITION IN AN OXYGEN VALVE WITHOUT HUMAN OR PROPERTY HARM. THERE WAS NO OFFICIAL COMPLAINT. THE CYLINDER ARRIVED TO THE SITE AS EMPTY WITH THE LABEL "DEFECTIVE". WHEN THE CYLINDER WAS VISUALLY CHECKED, IT APPEARED THAT SOMETHING WAS WRONG WITH THE MANOMETER (SOOT WAS JUST AROUND THE GAUGE) - MAYBE SOME LEAKAGE. IT WAS A NEW CYCLING FROM OCTOBER 2014, 7 TIMES FILLED. LAST FILLING WAS 11/10/2015. LIV VALVE NO: (B)(4). THE VALVE WAS OPENED AT LINDE (B)(4) FACILITY, WITH A TEAM OF DIFFERENT PERSONNEL FROM LINDE, BUT ALSO FROM GCE, FIRE DEPARTMENT AND OTHER. THE IGNITION LOOKED MUCH SMALLER COMPARED TO EARLIER IGNITIONS. WHEN IT WAS OPENED, IT LOOKED VERY CLEAN, NEARLY NOTHING WAS DAMAGED. IT COULD HARDLY BE SEEN THAT THERE HAD BEEN AN IGNITION, SO THE FILLING SYSTEM WAS CLEAN, O-RINGS WERE IN PLACE AND NOTHING BURNT. IT WAS FIRST WHEN THE SAFETY VALVE AND REGULATOR PISTOL WAS CHECKED, IT WAS FOUND THAT IT HAD BURNED. IT TURNED OUT TO BE LIKE A STANDARD IGNITION, MEANING THE SAME WAY AS PREVIOUS INCIDENTS, BUT A MUCH SMALLER BURNING AND NOBODY WAS HARMED. THE ROOT CAUSE HAS NOT BEEN SENT FOR ANALYSIS. THE FILLING CONNECTORS AND PIPES HAVE BEEN SENT TO CHECK THE CLEANLINESS, EVEN IF EVERYTHING LOOKED VERY CLEAN. ADD'L INFO IS EXPECTED. PHARMACOVIGILANCE COMMENTS: ACCIDENTAL SPONTANEOUS IGNITION IN OXYGEN CYLINDER VALVE. NO HUMAN OR MATERIAL HARM. VALVE SEND FOR EXTENSIVE INVESTIGATIONS SEARCHING FOR ROOT COURSE.