SENSICA UO SYSTEM
Received Jan 3, 2023 · Event occurred Dec 15, 2022
Report 1018233-2022-10070 · MDR key 16085848
Device
Generic name
Sensica Uo System
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
SCCS1002
Lot number
NA
Product problems
- Failure to Calibrate
- Failure to Calibrate
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS UNABLE TO BE DETERMINED, THE REPORTED ISSUE COULD NOT BE DUPLICATED DURING EVALUATION. IT WAS UNKNOWN WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE, HOWEVER THE DEVICE MET SPECIFICATIONS. THE REPORTED EVENT IS UNCONFIRMED, DHR REVIEW IS NOT REQUIRED. THE REPORTED EVENT IS UNCONFIRMED, LABELING/PACKAGING REVIEW IS NOT REQUIRED. CORRECTION- D, G, 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 DURING FIELD ACTION UPDATE THE SENSICA DEVICE FAILED CALIBRATION OF THE TOUCHSCREEN. AS PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 27DEC2022, THE DEVICE WAS COMING IN FOR REPAIR.
Description of Event or Problem
IT WAS REPORTED THAT DURING FIELD ACTION UPDATE THE SENSICA DEVICE FAILED CALIBRATION OF THE TOUCHSCREEN. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL ON 27DEC2022, THE DEVICE WAS COMING IN FOR REPAIR.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.