Description of Event or Problem · 1
CUSTOMER REPORTED A VACUUM REGULATOR EXPLODED WHEN THE VACUUM ADAPTER WAS INSERTED INTO THE VACUUM WALL OUTLET PRIOR TO A P[ROCEDURE ( NO PATIENT INVOLVEMENT). A NEW UNIT WAS CONNECTED TO THE SAME WALL VACUUM CONNECTOR. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER PROBLEMS NOTED. THERE WAS NO REPORTED PATIENT INJURY. THE HOSPITAL'S TECHNICAL TEAM FURTHER REPORTED THE GAS OUTLET CONFIGURATION IN EACH ROOM WILL BE ASSESSED FOR STANDARDIZATION TO ENABLE EACH ROOM TO BE IDENTICAL. OHMEDA MEDICAL AGREED TO PROVIDE AN EDUCATIONAL MEMO FOR CIRCULATION TO HOSPITAL PERSONNES. THE MEMO WILL DISCUSS THE REPORTED EVENT, ITS CAUSES, AND PREVENTIVE ACTION. THERE ARE APPROXIMATELY 30,000 UNITS IN THE FIELD WITH NO PREVIOUS HISTORY OF SIMILAR CONDITIONS FROM OTHER HOSPITALS. INVESTIGATION CONCLUSION:SAMPLE WAS FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE SAMPLE WAS EVALUATED, AND IT APPEARS THE UNIT WAS SUBJECTED TO EXCESSIVE FORCE CENTERED ON THE ADJUSTMENT KNOB IN THE OUTWARD DIRECTION. EVIDENCE SUGGESTS THIS WAS DUE TO USER ERROR, I.E AS OPPOSED TO VACUUM, THE UNIT WAS SUBJECTED TO POSITIVE PRESSURE., RESULTING IN EXPANSION OF THE BELLOWS AND DAMAGE TO THE UNIT. THE VACUUM REGULATOR INSTRTUCTIONS FOR USE CONTAINS A WARNING "CONNECTION TO PRESSURE SOURCES, EVEN MOMENTARILY, COULD INJURE THE PATIENT OR OPERATOR AND DAMAGE THE EQUIPMENT." TO FURTHER OHMEDA MEDICAL'S INVESTIGATION, A SITE VISIT WAS MADE TO GATHER ADDITIONAL INFORMATION. INSPECTION OF THE FACILITY'S WALL OUTLETS INDICATED ALL CEILING COLUMNS DO NOT HAVE VACUUM OUTLETS, AND SOME OUTLETS ARE MISSING THE LABELLING ENDICATING THE GAS OR VACUUM TYPE. THE HOSPITAL'S TECHNICAL TEAM REPORTED THEY WILL PREPARE LABELS FOR THE OUTLETS TO IMPROVE VISIBILITY OF THE GAS TYPE.