SENSICA UO SYSTEM

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 SCREEN OF THE SENSICA DEVICE WAS UNRESPONSIVE TO TOUCH. PER EMAIL RESPONSE RECEIVED ON 06JULY2022, BIOMED POWERED THE SENSICA ON AND THE SCREEN DID NOT RESPOND TO TOUCH. BIOMED POWERED IT DOWN AND UP AGAIN AND IT RESPONDED. CUSTOMER STATED THAT THIS HAS HAPPENED BEFORE. THE PROBLEM COULD BE INTERMITTENT. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE DEVICE WAS EVALUATED UPON RECEIPT. DEVICE WAS RUN FOR 120 HOURS WITH SIMULATED PATIENT AND RANDOM TOUCHSCREEN ACTIVITY; NO ISSUES OCCURRED. COMPLETED FINAL FUNCTIONAL TESTING. IT WAS UNKNOWN WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE, HOWEVER THE DEVICE MET SPECIFICATIONS. THE DEVICE WAS NOT IN USE ON A PATIENT. THE REPORTED EVENT IS UNCONFIRMED, DHR REVIEW IS NOT REQUIRED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿GENERAL WARNINGS MEDICAL ELECTRICAL EQUIPMENT REQUIRES SPECIAL PRECAUTIONS REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC) AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION PROVIDED IN THE CHARTS AT THE END OF THESE INSTRUCTIONS FOR USE (APPENDIX A). PORTABLE AND MOBILE RADIOFREQUENCY (RF) COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT. THE BD SENSICA¿ URINE OUTPUT SYSTEM SHOULD NOT BE STACKED WITH OTHER EQUIPMENT. THE BD SENSICA¿ URINE OUTPUT SYSTEM HAS A DEGREE OF PROTECTION AGAINST ELECTRIC SHOCK OF APPLIED PARTS CLASSIFIED AS TYPE BF. THIS DEVICE IS CLASSIFIED AS AN IEC CLASS I DEVICE. WHEN USING CLASS 1 XP POWER MODEL NUMBER: ALM65US12 POWER SUPPLY, TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH. DO NOT IMMERSE OR SUBMERGE THE BD SENSICA¿ URINE OUTPUT STAND, DISPLAY MONITOR, RING, TEMPERATURE MONITOR MODULE, TEMPERATURE SENSOR CABLES, OR MONOPLUG ADAPTER IN WATER OR OTHER LIQUIDS. DO NOT POUR LIQUIDS OVER THE DISPLAY MONITOR, RING, TEMPERATURE MONITOR, CABLES OR MONOPLUG ADAPTER. IF LIQUIDS ACCIDENTALLY SPILL ONTO THE DEVICE(S), WIPE OFF LIQUID WITH SOFT CLOTH AS SOON AS POSSIBLE. SEE SECTION 14 FOR COMPLETE CARE INSTRUCTIONS. THIS DEVICE IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE MIXTURES. THIS DEVICE IS NOT SUITABLE FOR USE IN OXYGEN RICH ENVIRONMENTS. THE USE OF TRANSDUCERS AND CABLES OTHER THAN THOSE SPECIFIED, WITH THE EXCEPTION OF TRANSDUCERS AND CABLES SOLD AS REPLACEMENT PARTS, MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE BD SENSICA¿ URINE OUTPUT SYSTEM. THE BD SENSICA¿ URINE OUTPUT SYSTEM IS DESIGNED TO BE USED WITH ANY BARD¿ FOLEY CATHETER AND UROLOGICAL DISPOSABLES CONNECTED TO ANY STANDARD URINE DRAINAGE BAG (2000 OR 2500 ML), WITH OR WITHOUT A URINE METER. IF USING A 400-SERIES TEMPERATURE-SENSING FOLEY CATHETER, SEE PRODUCT INSTRUCTIONS FOR USE FOR MRI COMPATIBILITY. REFER TO FOLEY CATHETER INSTRUCTIONS FOR USE FOR INDICATIONS AND FURTHER PRODUCT INFORMATION. IF USING A 400-SERIES TEMPERATURE-SENSING FOLEY CATHETER, THE OPERATOR IS RESPONSIBLE FOR ENSURING THE COMPATIBILITY OF THE TEMPERATURE SENSING FOLEY CATHETER TO THE BD SENSICA¿ URINE OUTPUT SYSTEM AND ITS ACCESSORIES. INCOMPATIBLE COMPONENTS CAN RESULT IN DEGRADED PERFORMANCE. NO MODIFICATION OF THE BD SENSICA¿ URINE OUTPUT SYSTEM OR ANY OF ITS ACCESSORIES IS ALLOWED. WARNING: THIS PRODUCT CAN EXPOSE YOU TO DI(2-ETHYLHEXYL) PHTHALATE (DEHP), WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM.¿ CORRECTION: D, H. 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 ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

Description of Event or Problem

IT WAS REPORTED THAT THE SCREEN OF THE SENSICA DEVICE WAS UNRESPONSIVE TO TOUCH. PER EMAIL RESPONSE RECEIVED ON 06JULY2022, BIOMED POWERED THE SENSICA ON AND THE SCREEN DID NOT RESPOND TO TOUCH. BIOMED POWERED IT DOWN AND UP AGAIN AND IT RESPONDED. CUSTOMER STATED THAT THIS HAS HAPPENED BEFORE. THE PROBLEM COULD BE INTERMITTENT. THERE WAS NO PATIENT INVOLVEMENT.