INFINITY DOCKING STATION

Description of Event or Problem

IT WAS COMMUNICATED TO US THAT WHILE THE CUSTOMER WAS USING OUR DELTA PT MONITOR THAT WAS CONNECTED TO OUR IDS (INFINITY DOCKING STATION) THE ANESTHESIOLOGIST SLIPPED AND HIT THE LOWER CORNER OF THE MONITOR WITH HIS ARM. THE MONITOR LIFTED OFF WITH THE UPPER PART OF THE DOCKING STATION AND RESULTED IN THE SEPARATION OF THE TOP COVER SECTION. (WHERE THE PT MONITOR IS MOUNTED) FROM THE BOTTOM SECTION OF THE IDS. NO PT INJURY WAS REPORTED.

Additional Manufacturer Narrative

THE MFR DRAEGER MEDICAL SYSTEMS, INC. RECEIVED THE IDS (INFINITY DOCKING STATION) CORRECTLY ASSEMBLED. A REPRESENTATIVE FROM THE MECHANICAL ENGINEERING GROUP EVALUATED THE ASSOCIATED IDS UNIT BY PERFORMING A SIMULATED FUNCTIONAL TEST BY INSTALLING A PT MONITOR ON THE ASSOCIATED IDS UNIT AND APPLYING FORCE IN A WAY TO POSSIBLY SEPARATE THE TOP COVER FROM THE IDS BASE COMPONENT. THE UNIT WAS ALSO DISASSEMBLED FOR FURTHER ANALYSIS. AN INSPECTION OF THE INTEGRITY OF THE PEM FASTENERS WAS PERFORMED. THIS INVOLVED THE REMOVAL OF THE IDS TOP COVER ASSEMBLY TO EXPOSE THE FASTENERS. EACH FASTENER WAS INSPECTED FOR PROPER INSERTION INTO THE MOLDED PLASTIC AND APPEARED TO BE FINE. THEN A TURNING FORCE WAS APPLIED TO EACH FASTENER TO DETERMINE IF THE PEM NUT COMPONENT WAS SECURELY IN PLACE AND WOULD NOT MOVE (SPIN OR PULL OUT). ALL PEM NUT FASTENERS STAYED IN PLACE, NONE MOVED OR PULLED OUT OF THE MOLDED PLASTIC BOSS. AFTER WE HAD PERFORMED THE ABOVE STATED TESTING, WE RECEIVED INFO FROM OUR LOCAL FIELD OFFICE THAT THE PEM FASTENERS HAD BEEN GLUED INTO THE MOLDED PLASTIC BOSSES AFTER THE REPORTED EVENT HAD OCCURRED. DUE TO THE APPLIED GLUE ON THE PEM FASTENERS, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED SEPARATION.