OHIO MEDICAL

Description of Event or Problem

USER FACILITY REPORTED TO (B)(4) MEDICAL CORPORATION SALES REP THAT A PUSH-TO-SET VACUUM REGULATOR STUCK IN THE OCCLUDED POSITION WHEN THE USER TURNED THE SELECTOR KNOB TO OBTAIN MAXIMUM VACUUM DURING AN EMERGENCY CODE.

Additional Manufacturer Narrative

THE (B)(4) MEDICAL SALES REP REPORTED THAT DURING HIS IN-SERVICE ROUNDS HE HAD SEVERAL DISCUSSIONS WITH NURSES WHO CLAIMED TO HAVE BEEN ACTIVE WITH THE CODE SITUATION THAT INVOLVED A PUSH TO SET SUCTION REGULATOR WHICH THEY CLAIMED DID NOT PROVIDE ANY VACUUM. THE NURSES REPORTED THE CONTROL KNOB WAS STUCK IN THE FULL VACUUM POSITION BUT DID NOT WORK. ONE OF THE NURSES SAID HE USED ANOTHER SUCTION REGULATOR AT THAT POINT. THE NURSES ALSO CLEARLY STATED THAT THIS PT WOULD NOT HAVE SURVIVED THIS CODE ANYHOW. WHEN ASKED BY THE SALES REP TO EXPLAIN, THE RESPONSE FROM THE NURSES WAS, "ALL I CAN TELL YOU IS THE PT WAS IN VERY CRITICAL CONDITION." A FORMAL INVESTIGATION INTO THE MALFUNCTION OF THE DEVICE IS UNDER WAY AT THE MANUFACTURING SITE.