SENSICA UO SYSTEM
Received Aug 17, 2023 · Event occurred Aug 1, 2023
Report 1018233-2023-06143 · MDR key 17566088
Device
Generic name
Sensica Uo System
Manufacturer
C.r. Bard, Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Circuit Failure
- Defective Component
- Circuit Failure
- Defective Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
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 SENSICA URINE OUTPUT DEVICE WAS CHECKED IN AND NO PHYSICAL DAMAGE PRESENT. THE DEVICE FAILED HI-POTS TEST.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA URINE OUTPUT DEVICE WAS CHECKED IN AND NO PHYSICAL DAMAGE PRESENT. THE DEVICE FAILED HI-POTS TEST.
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS A FAULTY BATTERY. THE DEVICE WAS EVALUATED UPON RECEIPT. THE UNIT FAILED HI-POTS TEST. THE BATTERY WAS REPLACED. A DHR IS NOT REQUIRED AS THIS IS NOT AN OUT-OF-BOX FAILURE. 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.