SENSICA UO MONITOR ICU
Received Mar 8, 2023 · Event occurred Feb 15, 2023
Report 1018233-2023-01546 · MDR key 16503095
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
SCCS1002
Lot number
NA
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND TO BE A DUPLICATE OF AN EVENT PREVIOUSLY REPORTED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.
Description of Event or Problem
IT WAS REPORTED THAT THE DURING THE EXECUTION OF REPROCESSING PROTOCOL SENSICA TOUCHSCREEN FIRMWARE UPDATE FIELD ACTION, AT THE US DEPOT, THE UNIT WAS GIVING THE TECHNICIAN A TUBE SENSOR ERROR WITH NO TUBE INSTALLED. PER REVIEW OF WO ON 22FEB2023, THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE DURING THE EXECUTION OF REPROCESSING PROTOCOL SENSICA TOUCHSCREEN FIRMWARE UPDATE FIELD ACTION, AT THE US DEPOT, THE UNIT WAS GIVING THE TECHNICIAN A TUBE SENSOR ERROR WITH NO TUBE INSTALLED. PER REVIEW OF WO ON (B)(6)2023, THERE WAS NO PATIENT INVOLVEMENT.