INTERMITTENT SUCTION REGULATOR

Additional Manufacturer Narrative

IN 2007, OHIO MEDICAL CORPORATION WAS NOTIFIED OF A USER FACILITY REPORT SUBMITTED REGARDING AN ALLEGEDLY DEFECTIVE VACUUM REGULATOR THAT WAS MANUFACTURED BY OHIO MEDICAL IN AUGUST OF 1996. THE FACILITY WAS CONTACTED ON 4/17/2007 TO SEE IF THEY WOULD RETURN THE UNIT FOR INVESTIGATION. THEY WOULD NOT RETURN IT. ON 5/1/2007, THE FACILITY WAS AGAIN ASKED IF THEY WOULD RETURN THE UNIT AND THEY STATED THAT THEY WOULD NOT RETURN IT. THE ALLEGED MALFUNCTION COULD NOT BE DUPLICATED BY THE FACILITY AND NO FURTHER INFORMATION COULD BE OBTAINED FROM THE INSTITUTION. THE FACT THAT THE DEVICE HAS MALFUNCTIONED COULD NOT BE ESTABLISHED BY THE HOSP OR OHIO MEDICAL. BASED ON THE COMPANY'S EXTENSIVE EXPERIENCE WITH THIS PRODUCT, WE BELIEVE THERE IS NO HEALTH HAZARD INDICATED BY THIS REPORT AND NO FURTHER INFO WILL BE SUBMITTED TO FDA.

Description of Event or Problem

IT WAS REPORTED THAT A PT HAD BEEN INTERMITTENTLY THROWING UP GREEN BILLIOUS FLUID DURING THE NIGHT. DURING ASSESSMENT AT 0900, NURSE FOUND THAT THE SUCTION HEAD WAS NOT FUNCTIONING. THE NASAL GASTRIC TUBE WAS HOOKED UP TO FUNCTIONING SUCTION HEAD. AFTER DEVICE REPLACED, ONE LITER FLUID DRAINED WITHIN THIRTY MINS.