SENSICA UO SYSTEM
Received Aug 31, 2023 · Event occurred Aug 11, 2023
Report 1018233-2023-06455 · MDR key 17661014
Device
Generic name
Sensica Urine Output System
Manufacturer
C.r. Bard, Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
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. 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 BIOMED STATED THE SENSICA DEVICE DID NOT READING THE BAG DURING 3 STEP CHECK AND IT WOULD NOT RECOGNIZED BAG. THE LOAD CELL WAS FAILED.
Description of Event or Problem
IT WAS REPORTED THAT THE BIOMED STATED THE SENSICA DEVICE DID NOT READING THE BAG DURING 3 STEP CHECK AND IT WOULD NOT RECOGNIZED BAG. THE LOAD CELL WAS FAILED.
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE REPORTED ISSUE WAS NOT REPLICATED IN DEPOT REPAIR. THE ISSUE WAS NOT CONFIRMED, UPDATES WERE MADE AS A PART OF THE SERVICE PROCEDURE. THE SENSICA DEVICE WAS EVALUATED. THE ISSUE WAS NOT REPLICATED IN THE DEPOT SERVICE. THE SENSICA DEVICE UNDERWENT SERVICE UPDATES, NEW GROUND WIRE AND OPTICAL SENSOR GASKET FOAM WAS APPLIED. LOAD CELL WAS FAILED. REPORTED ISSUE WAS NOT CONFIRMED. SERVICE UPDATES WERE MADE PER SERVICE PROCEDURE. THE DEVICE WORKED CORRECTLY OUT OF THE BOX AS WELL AS AFTER THE LOAD CELL RECALIBRATION/FINAL FUNCTIONAL VERIFICATION. THE REPORTED EVENT IS UNCONFIRMED, DHR REVIEW IS NOT REQUIRED. THE REPORTED EVENT IS UNCONFIRMED, LABELING/PACKAGING REVIEW IS NOT REQUIRED. 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.