SENSICA UO SYSTEM
Received Jun 23, 2025 · Event occurred Jun 18, 2025
Report 1018233-2025-04814 · MDR key 22307124
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Failure to Power Up
- Defective Component
- Failure to Power Up
- Defective Component
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THE 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 THEY EMAILED, THEY HAVE A SENSICA DEVICE, SN: (B)(6). THAT CAN ONLY MAINTAIN 10 MINUTES OF BATTERY LIFE. PER REVIEW OF WO, BIOMED SAYS THE DEVICE ONLY STAYS ON AFTER BEING UNPLUGGED FOR 10MINS. PLEASE FUNCTIONALLY VERIFY THE DEVICE AND IF THEY CAN TEST THAT IT REMAINS ON AFTER BEING UNPLUGGED FOR THE FULL 60 MIN COUNTDOWN.
Description of Event or Problem
IT WAS REPORTED THAT THEY EMAILED, THEY HAVE A SENSICA DEVICE, SN: (B)(6). THAT CAN ONLY MAINTAIN 10 MINUTES OF BATTERY LIFE. PER REVIEW OF WO, BIOMED SAYS THE DEVICE ONLY STAYS ON AFTER BEING UNPLUGGED FOR 10MINS. PLEASE FUNCTIONALLY VERIFY THE DEVICE AND IF THEY CAN TEST THAT IT REMAINS ON AFTER BEING UNPLUGGED FOR THE FULL 60 MIN COUNTDOWN.
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS A FAILED BATTERY. THE DEVICE WAS EVALUATED UPON RECEIPT. PERFORMED FULL DISCHARGE/CHARGE CYCLE ON THE DEVICE AS IS IT WAS SENT IN BY THE CUSTOMER, ONCE BATTERY READINGS SHOWED 100% CHARGE LEVEL AND 0.000 INPUT CURRENT TO BATTERY THE DEVICE WAS UNPLUGGED. ONCE UNPLUGGED, THE DEVICE IMMEDIATELY SHOWED 65% BATTERY LEVEL AND SHUT DOWN ROUGHLY 10-15 MINUTES AFTERWARDS. INSTALLED NEW BATTERY IN DEVICE AND THE DEVICE WAS ABLE TO PASS ALL REQUIREMENTS. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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.