Description of Event or Problem · 1
THIS IS A SPONTANEOUS MEDICAL DEVICE INCIDENT REPORT FROM (B)(6). ON THE (B)(6) 2015 A HOSPITAL WORKER HANDLED A 2 LITER ALUMINIUM CYLINDER WITH A NEW LIV-VALVE FROM (B)(6) 2015 (FROM GCE) CONTAINING CONOXIA (COMPRESSED MEDICAL OXYGEN) AND AN IGNITION OCCURRED. THE WORKER WAS NOT HARMED. PRESSURE IN THE CYLINDER BEFORE THE EVENT WAS 10 MPA. A WORKER IN THE ANESTHESIOLOGY AND RESUSCITATION DEPT WAS HOLDING THE CYLINDER WITH MEDICINAL OXYGEN IN HIS HAND. THE CYLINDER WAS NOT CONNECTED TO ANY OTHER DEVICE NOR PIPELINE. THE WORKER SHOULD OPEN THE CYLINDER VALVE AND SET THE REGULATED FLOW TO 3. AT THIS POINT, THERE WAS, ACCORDING TO HIS STATEMENT, IN THE FIRST SPARKING PHASE AND SUBSEQUENT FLAME COMBUSTION. AT THE SAME TIME THERE WAS AN ABRUPT PRESSURE RELEASE AND IMMEDIATE EMPTYING THE CONTENTS OF THE PRESSURE CYLINDER. CYLINDER SPECIFICATION AND IDENTIFICATION LIV - WATER CAPACITY 2 LITRES - ALUMINIUM CYLINDER (GCE). CYLINDER ID NUMBER: (B)(4). CYLINDER ICC BARCODE NUMBER: (B)(4). FILLING PRESSURE: 20MPA. COLOUR CODING: WHITE. ACTUAL PERIODICAL PRESSURE CHECK: (B)(6) 2015. INTEGRATED VALVE NUMBER: (B)(4). CYLINDER FILLING DATE: (B)(6) 2015. CYLINDER FILLING LOCATION: LINDE GAS (B)(4). DISTRIBUTION DATE: 11/19/2015. DISTRIBUTION POINT: LINDE GAS (B)(4). THE FIRE-BRIGADE HAVE TAKEN THE CYLINDER AND VALVE AND THESE WILL BE REQUESTED BACK TO LINDE FOR FURTHER INVESTIGATION. ADDITIONAL INFORMATION IS EXPECTED. PHARMOCOVIGILANCE COMMENTS: COMPLAINT REPORT FROM HEALTH CARE PROVIDER IN (B)(6) DESCRIBING AN ACCIDENTAL SPONTANEOUS IGNITION IN AN OXYGEN CYLINDER VALVE WHEN THE VALVE WAS OPENED. THE IGNITION AND FIRE WAS RAPIDLY CLOSED AND NO DAMAGE TO PROPERTY, AND NO PATIENT NOR PERSONNEL HARM WAS OBSERVED. THE VALVE IS UNDERGOING EXTENSIVE INTERNAL AND EXTERNAL INVESTIGATION SEARCHING FOR ROOT COURSE. FOR REPORTING IN ACCORDANCE TO REGULATIONS. (B)(4).