ISU, BSC, STD, CW DOM

Additional Manufacturer Narrative

DEVICE IS A VACUUM REGULATOR. THE DEVICE ACHIEVES ITS FUNCTION VIA A REGULATOR MODULE THAT IS EQUIPPED WITH A DIAPHRAGM. THE USER FILED A COMPLAINT THAT THE REGULATOR GAUGE WAS JUMPY. DURING THE INVESTIGATION OF THE RETURNED DEVICES IT WAS DISCOVERED THAT THE MALFUNCTIONING UNITS HAD THEIR DIAPHRAGMS TORN. THE USER DID NOT REPORT ANY PATIENT INVOLVEMENT NOR ANY ADVERSE EVENT. THE USER ALSO DID NOT FILE A FORM FDA-3500A. THE MANUFACTURER IS FILING FORM FDA-3500A BECAUSE THIS WAS A MALFUNCTION THAT IF IT WERE TO RECUR, IT WOULD HAVE THE POTENTIAL TO CAUSE SOME PATIENT HARM. INVESTIGATION INTO THE ROOT CAUSE IN ONGOING AS OF THE DATE OF THIS REPORT AND IT HAS NOT YET BEEN DETERMINED THE EXTENT TO WHICH REMEDIAL ACTION WOULD BE APPROPRIATE TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO PUBLIC HEALTH. THIS MALFUNCTION WAS PREVIOUSLY REPORTED ON 08/29/2014 (MFR REPORT # 1419185-2014-00003), HOWEVER, MULTIPLE DEVICES WERE INCLUDED ON THAT REPORT IN ERROR.

Description of Event or Problem

THE DEVICE IS A VACUUM REGULATOR INTENDED TO REGULATE SUCTION TO REMOVE BODY FLUIDS. ON (B)(6) 2014, IT WAS NOTED THAT 14 DEVICES WHICH HAD BEEN RETURNED FOR REPAIR CONTAINED DIAPHRAGMS WHICH HAD SIGNIFICANT TEARS IN THEM AFTER DEVICE LIFE OF LESS THAN 6 MONTHS. AT THE TIME ON QUALITY ASSURANCE AWARENESS ON (B)(6) 2014, PREVIOUS RETURNS WERE REVIEWED FURTHER TO DETERMINE IF ANY OTHER NEWER DEVICES HAD BEEN RETURNED WITH CONFIRMED DAMAGED DIAPHRAGMS. ONE ADDITIONAL DEVICE WAS NOTED. IT HAS BEEN DETERMINED THAT A TEAR IN THE REGULATOR DIAPHRAGM WHILE IN USE (AFTER VACUUM HAS BEEN SET) COULD RESULT IN AN INCREASE IN VACUUM TO THE PATIENT THAN WHAT HAD BEEN ORIGINALLY SET.