SENSICA UO SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE TABLET WOULD NOT TURN ON BUT WOULD NOT BOOT INTO APPLICATION. THE SENSICA DEVICE SCREEN GOES BLACK. THE DEVICE TO BE SENT TO PARTNER DEPOT FOR REPAIR. PER SUPPORT OR BIOMED TECHNICIAN VIA PHONE ON 21MAR2023, IT WAS REPORTED THAT THE EVENT HAPPENED ON 27FEB2023. THE DEVICE WAS NOT USED ON A PATIENT. THERE WAS NO INJURY TO A PATIENT OR INFORMATION AVAILABLE REGARDING A PATIENT. THERAPY WAS COMPLETED WITH ANOTHER DEVICE.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE OF THE REPORTED ISSUE COULD BE POWER SUPPLY SELECTION FAILURE. HOWEVER, THIS CANNOT BE CONFIRMED. THE DEVICE WAS NOT EVALUATED. PER ATTACHED DOCUMENTATION, THIS DEVICE IS OBSOLETE AND NO LONGER SERVICED. THE DEVICE WAS RETURNED WITHOUT REPAIR. DHR IS NOT REQUIRED AS THE REPORTED EVENT IS NOT AN OUT OF BOX FAILURE AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "1.1 INTRODUCTION THIS MANUAL PROVIDES THE INDICATIONS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE WITH THE BD SENSICA¿ URINE OUTPUT SYSTEM. CAREFULLY READ THIS MANUAL IN ITS ENTIRETY BEFORE USING THE BD SENSICA¿ URINE OUTPUT SYSTEM. FAILURE TO FOLLOW THESE INSTRUCTIONS MAY RESULT IN IMPROPER USE OF THIS DEVICE. CONTACT CUSTOMER SERVICE AT +1.844.823.5433 WITH ANY QUESTIONS ABOUT THE INFORMATION CONTAINED IN THIS MANUAL OR ABOUT THE OPERATION AND SAFETY OF THE BD SENSICA¿ URINE OUTPUT SYSTEM. 1.2 INDICATIONS FOR USE INDICATIONS: THE BD SENSICA¿ URINE OUTPUT SYSTEM IS AN AUTOMATED SYSTEM FOR CONTINUOUS MONITORING OF URINE OUTPUT (UO) AND CORE BLADDER TEMPERATURE WHEN CONNECTED TO A TEMPERATURESENSING FOLEY CATHETER. TARGET POPULATION: THE BD SENSICA¿ URINE OUTPUT SYSTEM IS INTENDED FOR BEDSIDE MONITORING OF URINE OUTPUT FOR ANY PATIENT WITH AN INDWELLING, UROLOGICAL CATHETER, DRAINAGE TUBING AND COLLECTION BAG, TYPICALLY IN CRITICAL CARE SETTINGS OR WHERE CLOSE MONITORING OF URINE OUTPUT IS DESIRED. THE BD SENSICA¿ URINE OUTPUT SYSTEM IS ALSO INTENDED FOR MONITORING CORE BLADDER TEMPERATURE WHEN USED WITH THE BD SENSICA¿ TEMPERATURE MONITOR MODULE AND A STANDARD, 400 SERIES TEMPERATURE-SENSING FOLEY CATHETER. 1.3 CONTRAINDICATIONS THERE ARE NO KNOWN CONTRAINDICATIONS FOR USE WITH PATIENTS WHO HAVE INDWELLING, UROLOGICAL CATHETERS IN PLACE. 1.4 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 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 2 PRODUCT. WHEN USING CLASS 1 POWER PARTNERS PEAMD72-10-B2 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, OR TEMPERATURE SENSOR CABLES IN WATER OR OTHER LIQUIDS. DO NOT POUR LIQUIDS OVER THE DISPLAY MONITOR, RING, TEMPERATURE MONITOR OR CABLES. IF LIQUIDS ACCIDENTALLY SPILL ONTO 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." 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 TABLET WOULD NOT TURN ON BUT WOULD NOT BOOT INTO APPLICATION. THE SENSICA DEVICE SCREEN GOES BLACK. THE DEVICE TO BE SENT TO PARTNER DEPOT FOR REPAIR. PER SUPPORT OR BIOMED TECHNICIAN VIA PHONE ON 21MAR2023, IT WAS REPORTED THAT THE EVENT HAPPENED ON (B)(6) 2023. THE DEVICE WAS NOT USED ON A PATIENT. THERE WAS NO INJURY TO A PATIENT OR INFORMATION AVAILABLE REGARDING A PATIENT. THERAPY WAS COMPLETED WITH ANOTHER DEVICE.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.