PUSH TO SET INTERMITTENT SUCTION REGULATOR

Additional Manufacturer Narrative

DURING MAUDE MONITORING ON (B)(6) 2017, USER REPORT (B)(4) WAS FOUND AND AN INTERNAL INVESIGATION WAS INITIATED. ON 5/11/2017 (B)(4) LLC RECEIVED A COPY OF THE USER FACILITY REPORT VIA USPS. SUMMARY OF (B)(4) MEDICAL LLCS INVESTIGATION CAN BE FOUND BELOW: ATTEMPTS TO CONTACT USER FACILITY TO GET MEDICAL DEVICE BACK FOR EVALUATION WERE UNSUCCESSFUL TO DATE, HOWEVER THE USER FACILITY CONFIRMED NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. AT APPROX 11:06AM ON 5/8/2017 A TELEPHONE MESSAGE WAS LEFT FOR (B)(4) TO DETERMINE IF THE DEVICE COULD BE SENT IN FOR EVALUATION. (B)(4) CALLED BACK AND PROVIDED CONTACT INFORMATION FOR (B)(4). ON 5/8/2017 (B)(4) WAS CONTACTED REQUESTING ADDITIONAL INFORMATION AS WELL AS DEVICE TO BE RETURNED FOR EVALUATION. (B)(4) FORWARDED THE MESSAGE ON TO (B)(4). ON 5/9/2017 (B)(4) RESPONDED STATING "WHAT WE REPORTED TO THE FDA WAS ALL WE KNOW ABOUT THIS CASE" AND THAT "I'M NOT SURE IF WE STILL HAVE THE DEVICE, BUT CAN CHECK". ON 5/11/2017 MEDWATCH 3500A WAS RECEIVED, AND ORIGINAL REPORTER, (B)(6) WAS CONTACTED. (B)(4) WAS UNCERTAIN IF DEVICE HAD BEEN SEQUESTERED AND REFERRED ME TO (B)(4). ON 5/12/2017 (B)(4) STATED "UNFORTUNATELY, WE DO NOT TRACK THOSE DEVICES. TYPICALLY, WHENEVER THERE IS A FAILURE, THE DEVICE GOES TO MATERIALS DISTRIBUTION AND GETS SENT OUT FOR REPAIR". ON 5/15/2017 (B)(4) STATED THAT SHE COULD NOT CONFIRM THAT THE DEVICE "WAS SEQUESTERED PROPERLY AFTER THE EVENT OCCURRED" AND THAT THE MATERIAL DISTRIBUTION DEPARTMENT WOULD TRY TO LOCATE THE DEVICE FOR RETURN. ON 5/16/2017 (B)(4) RESPONDED "UNFORTUNATELY WE ARE NOT ABLE TO FIND THE DEVICE. OUR MATERIALS DISTRIBUTION AREA IS GOING TO KEEP AN EYE OUT FOR IT, BUT THIS EVENT HAPPENED OVER A WEEKEND AND WE'VE BEEN UNABLE TO TRACK BACK TO FIND THE DEVICE. MY APOLOGIES..." NOTE: ON 5/16/2017 AND 5/31/2017 (B)(4) WAS CONTACTED TO REQUEST FACILITY SERVICE RECORDS FOR AFFECTED MEDICAL DEVICE FOR MANUFACTURER'S REVIEW.(B)(4) RESPONDED "I'M SORRY (B)(4) BUT I DON'T KNOW WHAT WAS DONE TO THE DEVICE PRIOR TO BE RETURNED TO SERVICE. MY APOLOGIES. WE ARE A BIG HOSPITAL AND EVERYONE I'VE TALKED TO ISN'T SURE WHAT HAPPENED." (B)(4) LLC REVIEWED PRODUCTION RECORDS FOR 450 UNITS (LOTS BEFORE, INCLUDING AND AFTER AFFECTED SERIAL NUMBER (B)(4) 9/30/2008) THERE WERE NO PRODUCTION ANAMOLIES OR DEVIATIONS THAT COULD HAVE AFFECTED THE PRODUCT. ADDITIONALLY, WE REVIEWED COMPLAINT DATA FOR AFOREMENTIONED LOTS AND FOUND TWO SERVICE REPORTS THAT DOCUMENTED NO CYCLE TIME FAILURES RELATED TO TIMING MODULE AND MANIFOLD. THESE COMPLAINTS, AS PART OF DATA TREND ANALYSIS OF POST MARKET SURVEILLANCE DATA, WERE WITHIN THE LIKLIHOOD IDENTIFIED IN OUR RISK ASSESSMENT PROFILE. (B)(4) LLC CONCLUDED THE INVESTIGATION BECAUSE WE COULD NOT GET THE DEVICE RETURNED FOR EVALUATION AND THE USER FACILITY HAS RETURNED THE AFFECTED MEDICAL DEVICE TO SERVICE AND IT IS OUR EXPECTATION THAT IT CURRENTLY MEETS MANUFACTURER SPECIFICATIONS. USER FACILITY UNABLE TO RETURN DEVICE

Description of Event or Problem

DURING MANUFACTURER MAUDE MONITORING ON (B)(6) 2017 USER REPORT (B)(4) WAS DISCOVERED, WHICH STATED THE FOLLOWING: "EVENT DESC: COMING ONTO SHIFT, WAS TOLD PATIENT HAD NG TO LOW INTERMITTENT SUCTION. WHEN PASSING MEDS AROUND 2000, WAS NOTICING THE SUCTION DEVICE ON THE WALL WAS NOT INTERMITTENTLY SUCTIONING, BUT WAS CONTINUOUSLY SUCTIONING. WALL DEVICE WAS SET TO INTERMITTENT SUCTION. MD NOTIFIED. THE PATIENTS NG WAS PLACED TO GRAVITY UNTIL ORDERS FOR INTERMITTENT SUCTION WERE RECEIVED AND NEW WALL UNIT WAS PLACED AND TESTED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? DECOMPRESSION".