SENSICA UO SYSTEM
Received Jun 4, 2024 · Event occurred Jan 19, 2024
Report 1018233-2024-03275 · MDR key 19460043
Device
Generic name
Sensica Uo System
Manufacturer
C.r. Bard, Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Circuit Failure
- Circuit Failure
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 REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS A FAILED POWER PCB. DEVICE WAS INTERMITTENTLY POWER CYCLING DURING EVALUATION. BCM AND WIRE CONNECTIONS WERE CHECKED AND ACCEPTABLE. INTERMITTENT POWER CYCLING CAN BE ATTRIBUTED TO FAILING POWER PCB BOARD. REPLACED PCB ASSEMBLY. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA URINE OUTPUT SYSTEM KEPT REBOOTING ON ITS OWN. WOULD BOOT TO THE GREEN PATIENT SCREEN AND THEN POWER CYCLE AND REPEAT. DEVICE WOULD BE SENT TO THE DEPOT FOR ASSESSMENT OF THE TOUCHSCREEN AND INTERNAL COMPONENTS.