VACUUM REGULATOR
Received Feb 12, 2013 · Event occurred Oct 16, 2012
Report 1924066-2013-00001 · MDR key 3002041
Device
Product problems
- Device Operates Differently Than Expected
- Pressure Problem
Patient
67 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE CALLED AND SENT E-MAIL TO REPORTING MEDICAL CENTER REQUESTING FURTHER INFORMATION. WE HAVE NOT YET RECEIVED ANY FURTHER INFORMATION. WE MANUFACTURE A NUMBER OF DIFFERENT VACUUM REGULATORS. WE DO NOT KNOW WHICH VACUUM REGULATORS THEY ARE REFERRING TO. WE ALSO DO NOT KNOW IF IT'S THE MODEL WHICH SHOULD BE USED FOR THIS APPLICATION. THEY DID NOT LIST A DATA CODE OR LOT NUMBER WE USE. THEREFORE WE DO NOT KNOW HOW HOLD THIS UNIT IS. WE HAVE BEEN MAKING VACUUM REGULATORS SINCE THE 1950'S. WE DO NOT KNOW WHAT KIND OF VACUUM SOURCE THEY WERE USING OR WHAT LEVEL OF VACUUM IT WAS PRODUCING. WE DO NOT KNOW HOW THIS PIECE OF EQUIPMENT WAS SET UP WITH THE VACUUM REGULATOR. AT 30 MMHG THE VACUUM IS JUST SLIGHTLY TURNED ON. THEREFORE ANY LEAKS IN THE SYSTEM BEING USED MAY CAUSE THE VACUUM LEVEL TO VARY. SINCE WE DO NOT KNOW ANY OF THE DETAILS INCLUDING WHICH VACUUM REGULATOR WAS INVOLVED WE ARE SUBMITTING THIS REPORT AS REQUIRED AND WILL INVESTIGATE FURTHER IF INFORMATION IS PROVIDED. WITHOUT A MODEL NUMBER OR PICTURES WE CANNOT DETERMINE IF THIS VACUUM REGULATOR IS OURS.
Description of Event or Problem
IT WAS REPORTED THAT ROBOTIC MVR WAS BEING PUMPED IN PREPARATION FOR A PROCEDURE. SURGEON REQUESTED VACUUM SET AT -40 MMHG. LATER IN THE CASE, THEY ATTEMPTED TO REDUCE VACUUM TO -30 MMHG. UNIT WAS UNABLE TO MAINTAIN CONSTANT PRESSURE.