SENSICA UO SYSTEM

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS DUE TO A DAMAGED LOAD CELL PIN. IT HAS BEEN CONFIRMED THAT A DAMAGED LOAD CELL COULD CAUSE A DEVICE TO POWER CYCLE. LOAD CELL WAS REPLACED. TESTING WAS PERFORMED. THE INSTRUCTIONS-FOR-USE ARE FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. CORRECTION: B,D,F,H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 SENICA DEVICE INTERMITTENTLY REBOOTS. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 06MAY2025, SPOKE WITH BIOMED, WHO CONFIRMED NO PATIENT INVOLVED AT THE TIME OF THE MALFUNCTION. THIS DEVICE WILL BE COMING INTO DEPOT FOR REPAIR.

Additional Manufacturer Narrative

INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 SENICA DEVICE INTERMITTENTLY REBOOTS.