Description of Event or Problem · 0
ON (B)(6) 2022 OHIO MEDICAL WAS MADE AWARE OF A MALFUNCTION IN WHICH THE CUSTOMER STATED THAT ONE OF THE FLOWMETER TUBES RUPTURED DURING USE. THE ASSEMBLY FITTING AND ADJACENT FLOWMETER WERE NOT AFFECTED. NEARBY PATIENTS WERE NOT HARMED. THE DEVICE ASSEMBLY WAS RETURNED TO OHIO MEDICAL ON (B)(6) 2022 AND WAS EVALUATED BY ENGINEERING. IT WAS NOTED THAT FLOWMETER THAT WAS NOT IMPACTED WAS UNABLE TO BE DISASSEMBLED. THERE APPEARED TO BE A FOREIGN ADHESIVE APPLIED TO THE THREADS OF THE HOOD. UPON FURTHER EVALUATION IT WAS NOTED THAT THE HOOD THREADING OF THE IMPACTED FLOWMETER WAS SEVERELY BURNT; THIS COULD BE DUE TO A FOREIGN MATERIAL/ADHESIVE. IT WAS CONCLUDED THAT USER FACILITY UTILIZED AN ADHESIVE TO JOIN THE FLOWMETER HOOD AND MANIFOLD. OHIO MEDICAL HAS BEEN UNABLE TO DETERMINE WHAT TYPE OF ADHESIVE WAS USED THROUGHOUT INTERVIEWS WITH THE USER FACILITY. DEVICE INSTRUCTIONS FOR USE (ATTACHED) PAGE 2 STATES "TO MINIMIZE THE RISK OF EXPLOSION OR FIRE: NEVER USE GREASE, OIL, ORGANIC LUBRICANTS, OR FLAMMABLE MATERIALS ON OR NEAR THE FLOWMETER AND NEVER USE ANY TYPE OF FLAME OR FLAMMABLE OR EXPLOSIVE MATERIAL NEAR THE FLOWMETER." IT WAS ALSO NOTED THAT THE IMPACTED FLOWMETER WAS MISSING THE MESH SCREEN WHICH IS DESIGNED TO PREVENT IMPURITIES FROM ENTERING THE DEVICE FROM THE SOURCE GAS (OXYGEN TANK OR OXYGEN WALL OUTLET). THE DEVICE SHIPPED FROM OHIO MEDICAL ON OCTOBER 26, 2011. OHIO MEDICAL CONCLUDED THAT THE PRODUCT WAS ADULTERATED BY THE END USER. THE UNKNOWN ADHESIVE ALONG WITH THE MISSING MESH SCREEN LIKELY CONTRIBUTED TO THIS MALFUNCTION.