SENSICA UO MONITOR ICU

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT WORKING AND THE ONLY WAY THE USER COULD GET IT TO WORK WAS BY REPLACING THE RING . THERE WAS NO PATIENT HOOKED UP TO THE DEVICE AND THE CHARGE NURSE INDICATED THAT THEY COULD NOT RESTART THE UNIT. REPRESENTATIVE TRIED TO RESTART THE UNIT AND VERIFIED THAT AFTER PUSHING THE POWER BUTTON, THE GRAPHIC USER INTERFACE SCREEN CAME UP ASKING IF THEY WERE SURE TO RESTART AND THE YES OPTION COULD NOT BE PRESSED . ADDITIONALLY, OTHER BUTTONS ON THE MAIN GRAPHIC USER INTERFACE WERE UNRESPONSIVE. FURTHER VISUAL INSPECTION OF THE SCREEN INDICATED THAT THERE WAS A PERSISTENT PHANTOM TOUCH THAT SHOWED UP AS A CIRCLE ON THE SCREEN. THE PERSISTENT PHANTOM TOUCH WAS DETERMINED TO BE THE CAUSE FOR WHY THE SCREEN WAS UNRESPONSIVE. A RESTART OF THE UNIT WAS TRIGGERED BY ATTACHING AND DETACHING THE RING MULTIPLE TIMES. REPRESENTATIVE STATED THAT UPON RESTART, THE PHANTOM TOUCH DISAPPEARED, AND THE SCREEN WAS FULLY FUNCTIONAL. AS PER ADDITIONAL INFORMATION RECEIVED ON 20JUN2022, THE ARCTIC SUN DEVICE WAS PULLED FROM THE FLOOR WITH A DO NOT USE STICKER, WITH NO ADDITIONAL DETAIL. THE UNIT WAS THEN GIVEN TO BD REPRESENTATIVE TO INVESTIGATE, THEY BROUGHT THE UNIT TO OUR CONFERENCE ROOM AND STARTED A MONITORING SESSION TO TRY IT OUT AND SEE IF IT WORKED. THEY ATTEMPTED TO ADD SOME WEIGHT TO SEE IF THE DEVICE WAS RECORDING CORRECTLY. AT FIRST, THEY TRIGGERED A SUDDEN INCREASE POSSIBLE ARTIFACT ALARM, AND REMOVED THE WEIGHT DURING STABILIZATION. THE DEVICE STABILIZATION ENDED AND DISPLAYED 0 ML. WHILE LOOKING OVER THE DEVICE, WE TILTED IT AND TRIGGERED THE TILT ALARM A FEW TIMES. THEY ADDED SOME FLUID TO THE BAG, AND WAS ABLE TO INCREASE IT TO APPROXIMATELY 15 ML. THERE WAS A RANDOM JUMP UP TO ABOUT 69 ML THAT THEY CANNOT ACCOUNT FOR . THE HOUR ENDED, AND THE DEVICE DISPLAYED ONLY THE NEW CURRENT HOUR. THEY ADDED ABOUT 10 ML WHICH IT READ AND CHECKED THE DATA SCREEN AND THE DATA FROM THE PREVIOUS HOUR WAS STILL PRESENT. WHEN RETURNING TO THE MAIN SCREEN IT STILL DID NOT SHOW THE FIRST PARTIAL HOUR. ONCE THE HOUR WAS UP, THE DEVICE CREATED A NEW HOUR AND STARTED DISPLAYING THE FIRST PARTIAL HOUR AS WELL (NEW HOUR WITH OLD MISSING HOUR).

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED AS DESIGN RELATED. THE IDENTIFIED ROOT CAUSES IS ¿SOFTWARE ISSUES¿ AS IT WAS CONFIRMED THAT DUE TO CERTAIN SOFTWARE STEPS BEING INTERRUPTED, THAT UO WAS NOT BEING REPORTED OR CALCULATED CORRECTLY. FURTHERMORE, MULTIPLE CONTRIBUTING FACTORS WERE IDENTIFIED FOR THE UO ACCURACY ISSUE UNDER EVALUATION: ¿AMBIGUOUS IFU¿, ¿UNGRACEFUL SHUTDOWN,¿ ¿NOT FOLLOWING IFU,¿ ¿POWER ISSUES,¿ ¿SOFTWARE ANOMALY ASSESSMENT,¿ ¿PRODUCT ACQUISITION EVALUATION AND INTEGRATION,"" AND ¿ICU LAYOUT¿. HOWEVER, ALL THE CONTRIBUTING FACTORS ARE CORRELATED TO THE DISRUPTING SOFTWARE OPERATIONS PARTICULARLY WITH RELATION TO THE POWER SUPPLY AND UNGRACEFUL SHUTDOWNS. IT WAS A COMBINATION OF THE UNGRACEFUL SHUTDOWNS THAT FORCED THE SOFTWARE ISSUES TO BE IDENTIFIED WITH INCREASING PRECEDENCE. THESE ISSUES WERE PREVIOUSLY THOUGHT TO BE A LOWER RISK LEVEL, BUT THE CURRENT COMPLAINTS SHOW THAT THIS ASSESSMENT WAS INACCURATE. ALL GOOD FAITH ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. THE OUTCOME OF THE REPAIR COULD NOT BE DETERMINED AT THIS TIME. THE DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED. LABELING REVIEW WAS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THIS ISSUE.H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT WORKING AND THE ONLY WAY THE USER COULD GET IT TO WORK WAS BY REPLACING THE RING . THERE WAS NO PATIENT HOOKED UP TO THE DEVICE AND THE CHARGE NURSE INDICATED THAT THEY COULD NOT RESTART THE UNIT. REPRESENTATIVE TRIED TO RESTART THE UNIT AND VERIFIED THAT AFTER PUSHING THE POWER BUTTON, THE GRAPHIC USER INTERFACE SCREEN CAME UP ASKING IF THEY WERE SURE TO RESTART AND THE YES OPTION COULD NOT BE PRESSED . ADDITIONALLY, OTHER BUTTONS ON THE MAIN GRAPHIC USER INTERFACE WERE UNRESPONSIVE. FURTHER VISUAL INSPECTION OF THE SCREEN INDICATED THAT THERE WAS A PERSISTENT PHANTOM TOUCH THAT SHOWED UP AS A CIRCLE ON THE SCREEN. THE PERSISTENT PHANTOM TOUCH WAS DETERMINED TO BE THE CAUSE FOR WHY THE SCREEN WAS UNRESPONSIVE. A RESTART OF THE UNIT WAS TRIGGERED BY ATTACHING AND DETACHING THE RING MULTIPLE TIMES. REPRESENTATIVE STATED THAT UPON RESTART, THE PHANTOM TOUCH DISAPPEARED, AND THE SCREEN WAS FULLY FUNCTIONAL. PER ADDITIONAL INFORMATION RECEIVED ON 20JUN2022, THE SENSICA DEVICE WAS PULLED FROM THE FLOOR WITH A DO NOT USE STICKER, WITH NO ADDITIONAL DETAIL. THE UNIT WAS THEN GIVEN TO BD REPRESENTATIVE TO INVESTIGATE, THEY BROUGHT THE UNIT TO THE CONFERENCE ROOM AND STARTED A MONITORING SESSION TO TRY IT OUT AND SEE IF IT WORKED. THEY ATTEMPTED TO ADD SOME WEIGHT TO SEE IF THE DEVICE WAS RECORDING CORRECTLY. AT FIRST, THEY TRIGGERED A SUDDEN INCREASE POSSIBLE ARTIFACT ALARM, AND REMOVED THE WEIGHT DURING STABILIZATION. THE DEVICE STABILIZATION ENDED AND DISPLAYED 0 ML. WHILE LOOKING OVER THE DEVICE, THEY TILTED IT AND TRIGGERED THE TILT ALARM A FEW TIMES. THEY ADDED SOME FLUID TO THE BAG, AND WAS ABLE TO INCREASE IT TO APPROXIMATELY 15 ML. THERE WAS A RANDOM JUMP UP TO ABOUT 69 ML THAT THEY COULD NOT ACCOUNT FOR. THE HOUR ENDED, AND THE DEVICE DISPLAYED ONLY THE NEW CURRENT HOUR. THEY ADDED ABOUT 10 ML WHICH IT READ, AND THEY CHECKED THE DATA SCREEN AND THE DATA FROM THE PREVIOUS HOUR WAS STILL PRESENT. WHEN RETURNING TO THE MAIN SCREEN, IT STILL DID NOT SHOW THE FIRST PARTIAL HOUR. ONCE THE HOUR WAS UP, THE DEVICE CREATED A NEW HOUR AND STARTED DISPLAYING THE FIRST PARTIAL HOUR AS WELL THE NEW HOUR WITH OLD MISSING HOUR.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT WORKING AND THE ONLY WAY THE USER COULD GET IT TO WORK WAS BY REPLACING THE RING . THERE WAS NO PATIENT HOOKED UP TO THE DEVICE AND THE CHARGE NURSE INDICATED THAT THEY COULD NOT RESTART THE UNIT. REPRESENTATIVE TRIED TO RESTART THE UNIT AND VERIFIED THAT AFTER PUSHING THE POWER BUTTON, THE GRAPHIC USER INTERFACE SCREEN CAME UP ASKING IF THEY WERE SURE TO RESTART AND THE YES OPTION COULD NOT BE PRESSED . ADDITIONALLY, OTHER BUTTONS ON THE MAIN GRAPHIC USER INTERFACE WERE UNRESPONSIVE. FURTHER VISUAL INSPECTION OF THE SCREEN INDICATED THAT THERE WAS A PERSISTENT PHANTOM TOUCH THAT SHOWED UP AS A CIRCLE ON THE SCREEN. THE PERSISTENT PHANTOM TOUCH WAS DETERMINED TO BE THE CAUSE FOR WHY THE SCREEN WAS UNRESPONSIVE. A RESTART OF THE UNIT WAS TRIGGERED BY ATTACHING AND DETACHING THE RING MULTIPLE TIMES. REPRESENTATIVE STATED THAT UPON RESTART, THE PHANTOM TOUCH DISAPPEARED, AND THE SCREEN WAS FULLY FUNCTIONAL. AS PER ADDITIONAL INFORMATION RECEIVED ON 20JUN2022, THE ARCTIC SUN DEVICE WAS PULLED FROM THE FLOOR WITH A DO NOT USE STICKER, WITH NO ADDITIONAL DETAIL. THE UNIT WAS THEN GIVEN TO BD REPRESENTATIVE TO INVESTIGATE, THEY BROUGHT THE UNIT TO OUR CONFERENCE ROOM AND STARTED A MONITORING SESSION TO TRY IT OUT AND SEE IF IT WORKED. THEY ATTEMPTED TO ADD SOME WEIGHT TO SEE IF THE DEVICE WAS RECORDING CORRECTLY. AT FIRST, THEY TRIGGERED A SUDDEN INCREASE POSSIBLE ARTIFACT ALARM, AND REMOVED THE WEIGHT DURING STABILIZATION. THE DEVICE STABILIZATION ENDED AND DISPLAYED 0 ML. WHILE LOOKING OVER THE DEVICE, WE TILTED IT AND TRIGGERED THE TILT ALARM A FEW TIMES. THEY ADDED SOME FLUID TO THE BAG, AND WAS ABLE TO INCREASE IT TO APPROXIMATELY 15 ML. THERE WAS A RANDOM JUMP UP TO ABOUT 69 ML THAT THEY CANNOT ACCOUNT FOR . THE HOUR ENDED, AND THE DEVICE DISPLAYED ONLY THE NEW CURRENT HOUR. THEY ADDED ABOUT 10 ML WHICH IT READ AND CHECKED THE DATA SCREEN AND THE DATA FROM THE PREVIOUS HOUR WAS STILL PRESENT. WHEN RETURNING TO THE MAIN SCREEN IT STILL DID NOT SHOW THE FIRST PARTIAL HOUR. ONCE THE HOUR WAS UP, THE DEVICE CREATED A NEW HOUR AND STARTED DISPLAYING THE FIRST PARTIAL HOUR AS WELL (NEW HOUR WITH OLD MISSING HOUR).