SENSICA UO SYSTEM
Received Sep 25, 2023 · Event occurred Sep 12, 2023
Report 1018233-2023-07036 · MDR key 17807493
Device
Generic name
Sensica Uo System
Manufacturer
C.r. Bard, Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Defective Component
- Failure to Calibrate
- Defective Component
- Failure to Calibrate
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS A FAILED BCM. A DHR IS NOT REQUIRED AS THIS IS EVENT NOT AN OUT-OF-BOX FAILURE AND THEREFORE IS NOT MANUFACTURING RELATED. THE REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA URINE OUTPUT SYSTEM TOUCHSCREEN NEED UPDATE AND FAILED BCM DURING CALIBRATION.
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 SENSICA URINE OUTPUT SYSTEM TOUCHSCREEN NEED UPDATE AND FAILED BCM DURING CALIBRATION.